ADVENTURE MEDICAL KITS 1-2 PERSON FIRST AID (BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACET

ADVENTURE MEDICAL KITS 1-2 PERSON FIRST AID (BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACET
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NDC 44224-2000-1, 47682-175-46, 47682-182-46, 52124-0001-1, 52124-0003-1, 52124-0008-1, 52124-0009-1, 52124-0011-1
Set ID 0adedf0d-6c71-4ed9-963f-1fc41c1ae0f6
Category HUMAN OTC DRUG LABEL
Packager Tender Corp dba Adventure Medical Kits
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active Ingredient: .........Bacitracin Zinc 400 units

    Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)

    Polymyxin B Sulfate 5000 units

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  • PURPOSE

    Uses:  To help prevent infection in:
    minor cuts;  scrapes;  burns

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  • WARNINGS

    Warnings:

    For external use only.

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  • DO NOT USE

    Do not use:  in eyes;  over large areas of the body;

    If allergic to any of the ingredients;  for more than one week unless directed by a physician.

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  • STOP USE

    Stop use and consult a doctor:

    if the condition persists or gets worse;  a rash or other allergic reaction develops

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If ingested, contact a Poison

    Control Center right away.

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  • WHEN USING

    Directions: clean affected area;  apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage

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  • STORAGE AND HANDLING

    Other information:

    Store at room temperature.

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  • PRINCIPAL DISPLAY PANEL

    Genuine Triple Antibiotic

    First Aid Ointment

    To Help Prevent Infection

    Each Gram Contains:

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg

    (equivalent to 3.5 mg

    Neomycin base)

     Polymyxin B Sulfate 5000 units

    Net Wt. 0.5g ; (1/64 oz)

    Manufactured in CHINA for

    GENUINE FIRST AID.

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  • ACTIVE INGREDIENT

    Active Ingredient:                           Purpose:

    Benzocaine, 6% w/v..................    Topical Anesthetic

    SD alcohol, 60% w/v..................   Antiseptic

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  • PURPOSE

    Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

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  • WARNINGS

    Warnings: For external use only.

    Avoid contact with eyes.  If this happens, rinse thoroughly with water.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

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  • STORAGE AND HANDLING

    Flammable - keep away from fire or flame.

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  • DO NOT USE

    Do not use: In eyes, on broken skin, deep puncture wounds.  If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

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  • DESCRIPTION

    Made in CHINA

    LOT/EXP:

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  • PRINCIPAL DISPLAY PANEL

    Insect Sting Relief Pad


    Genuine First Aid LLC, Clearwater FL 33755
                            www.GenuineFirstAid.com

    1/pouch

    GENUINE FIRST AID
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  • ACTIVE INGREDIENT


    Active ingredient (in each tablet)                       Purpose

    Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer

    *nonsteroidal anti-inflammatory drug

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  • PURPOSE


    Uses temporarily relieves minor aches and pains due to:

    the common cold

    headache

    toothache

    muscular aches

    backache

    minor pain of arthritis

    menstrual cramps temporarily reduces fever
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  • WARNINGS



    Warnings

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock,  facial swelling,  asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach
    bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed
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  • DO NOT USE


    Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer,  right before or after heart surgery.

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  • ASK DOCTOR

    Ask a doctor before use if  stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic
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  • ASK DOCTOR/PHARMACIST


    Ask a doctor before use if you are:
    taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug
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  • WHEN USING

    When using this product:
    take with food or milk if stomach upset occurs
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  • STOP USE

    Stop use and ask a doctor If:
    you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
    Close
  • DOSAGE & ADMINISTRATION

    Directions:
    do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.

    Adults and Children (12 years and older):  Take 1 tablet every 4 to 6 hours while symptoms persist.  If pain or fever does not respond to 1 tablet, 2 tablets may be used.  Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

    Children under 12 years: Do not give to children under 12 years of age.


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  • STORAGE AND HANDLING


    Other information:  Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets
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  • INACTIVE INGREDIENT

    Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

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  • DESCRIPTION

    Distributed by GENUINE FIRST AID
    600 Cleveland Str Suite 400, Clearwater, FL 33755

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  • PRINCIPAL DISPLAY PANEL

    IBUPROFEN 2 Tablets

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  • PRINCIPAL DISPLAY PANEL

    IBUPROFEN   2 Tablets

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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)                      Purpose

    Aspirin (NSAID*) 325 mg...............................   Pain Reliever / fever reducer

    *nonsteroidal anti-inflammatory drug 

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  • PURPOSE

    Uses   Temporarily relieves minor aches and pains associated with:
    headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever

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  • WARNINGS

    Warnings

    Reye's syndrome:  Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product.  When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert:   Aspirin may cause a severe allergic reaction which may include:  hives, skin reddening, facial swelling, rash,  asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning:   This contains an NSAID, which may cause severe stomach bleeding.  The chance is higher if you:
    are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed

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  • DO NOT USE

    Do not use:  if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis

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  • ASK DOCTOR

    Ask a doctor before use if: stomach bleeding warning applies to you;  you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

    Close
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are:

    under a doctor's care for any serious condition;  taking any other drug

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  • WHEN USING

    When using this product: take with food or milk if stomach upset occurs

    Close
  • STOP USE


    Stop use and ask a doctor if
    you experience any of the following signs of stomach bleeding:
    feel faint;  vomit blood; have bloody or black stools; have stomach
    pain that does not get better; pain gets worse or lasts more than 10 days;  fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or

    contact a Poison Control Center right away.

    Close
  • WHEN USING

    Directions

    do not use more than directed

    the smallest effective dose should be used

    drink a full glass of water with each dose

    do not take longer than 10 days, unless directed by a doctor


    Close
  • DOSAGE & ADMINISTRATION

    Adults and children: (12 years and older) Take 1 or 2 tablets with

    water every 4 hours as needed.  Do not take more than 12 tablets in 24

    hours, or as directed by a doctor.

    Children under 12 years:   Do not give to children under 12 years of age.

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  • STORAGE AND HANDLING

    Store at 59 - 86  degree Fahrenheit (15 - 30 degree Celsius); avoid

    excessive heat and humidity;  tamper evident sealed packets;

    Do not use any opened or torn packets

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  • INACTIVE INGREDIENT

    Inactive Ingredients:  hypromellose, polyethylene glycol, propylene glycol, corn starch

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  • DESCRIPTION

    Distributed by GENUINE FIRST AID
    600 Clevelad Str Suite 400, Clearwater, FL 33755
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  • PRINCIPAL DISPLAY PANEL

    ASPIRIN 2 Tablets
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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)                      Purpose

    Acetaminophen 500 mg...............................   Pain Reliever / fever reducer


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  • PURPOSE

    Purpose: Pain reliever, fever reducer

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  • INDICATIONS & USAGE

    Uses   for the temporary relief of minor aches and pains associated with
    headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever

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  • WARNINGS

    Warnings

    Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.

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  • DO NOT USE

    Do not use:  with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist.
    for more than 10 days for pain unless directed by a doctor
    for more than 3 days for fever unless directed by a doctor

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  • ASK DOCTOR

    Ask a doctor before use if you have liver disease

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    Stop using and ask a doctor if
    symptoms do not improve
    new symptoms occur
    pain or fever persists or gets worse
    redness or swellign is present

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • DOSAGE & ADMINISTRATION

    Adults and children: (12 years and older)
    take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

    Children under 12 years:
    do not give to children under 12 years of age.

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  • STORAGE AND HANDLING

    Store at 59 - 86  degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967

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  • INACTIVE INGREDIENT

    Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.

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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)                      Purpose

    Diphenhydramine Hydrochloride 25mg...............................   Antihistimine


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  • PURPOSE

    Purpose: Antihistimine

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  • INDICATIONS & USAGE

    Uses   Temporarily relieves the following symptoms associated with hay fever or other upper respiratory allergies:
    runny nose, sneezing, itching of the nose or throat, itchy, watery eyes

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  • STORAGE AND HANDLING

    Store at room temperature. Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967

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  • WARNINGS

    Warnings

    Ask a doctor before use
    if you have:
    a breathing problem such as emphysema or chronic bronchitis
    glaucoma
    difficulty in urination due to enlargement of the prostate gland

    if you are:
    taking any drugs for asthma
    taking sedatives or tranquilizers

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  • WHEN USING

    When using this product

    Drowsiness may occur

    avoid alcoholic beverages

    alcohol, sedatives, and tranquilizers may increase the drowsiness effect

    use caution when driving a motor vehicle or operating machinery

    excitaility may occur, especially in children

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  • KEEP OUT OF REACH OF CHILDREN

    Do not exceed recommended dosage. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or posion control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

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  • DOSAGE & ADMINISTRATION

    Adults and children: (12 years and older)
    take 1 capsule every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

    Children under 12 years:
    do not give to children under 12 years of age unless directed by a doctor.

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  • INACTIVE INGREDIENT

    Inactive Ingredients:DandC Red 28, FDandC Blue 1, FDandC Red 40, gelatin, starch

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  • ACTIVE INGREDIENT

    Active Ingredient:                                 Purpose

    Benzalkonium Chloride 0.40%..........   First Aid Antiseptic

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  • PURPOSE

    Use: For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

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  • WARNINGS

    Warning:   For external use only.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:  If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • STOP USE

    Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

    Close
  • DO NOT USE

    Do not use in the eyes or over large areas of the body.

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  • WHEN USING

    Directions: Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.


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  • INACTIVE INGREDIENT

    Inactive Ingredient:   Purified water


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  • DESCRIPTION

    LOT/EXP:                           Made in CHINA

    20130301

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  • PRINCIPAL DISPLAY PANEL

    Antiseptic Towelette

    Genuine First Aid LLC, Clearwater FL 33755

    www.GenuineFirstAid.com

    1/pouch

    GENUINE FIRST AID

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  • INGREDIENTS AND APPEARANCE
    ADVENTURE MEDICAL KITS 1-2 PERSON FIRST AID  
    benzalkonium chloride, aspirin, ibuprofen, isopropyl alcohol, benzocaine, sd alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, acetaminophen, diphenhydramine chloride kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:44224-2000
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44224-2000-1 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 2 TUBE 1 g
    Part 2 2 PACKAGE 1 mL
    Part 3 4 PACKET
    Part 4 2 PACKET
    Part 5 3 PACKET
    Part 6 2 PACKAGE
    Part 7 10 PACKAGE 8 mL
    Part 1 of 7
    GENUINE TRIPLE ANTIBIOTIC  
    bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
    Product Information
    Item Code (Source) NDC:52124-0003
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0003-1 .5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 08/26/2010
    Part 2 of 7
    INSECT STING RELIEF PAD  
    benzocaine,alcohol swab
    Product Information
    Item Code (Source) NDC:52124-0008
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6 mL  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 60 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0008-1 0.5 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 08/26/2010
    Part 3 of 7
    IBUPROFEN  
    ibuprofen tablet
    Product Information
    Item Code (Source) NDC:52124-0009
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color white (WHITE) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 44;352
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0009-1 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075010 08/26/2010
    Part 4 of 7
    MEDIQUE DIPHEN 
    diphenhydramine hydrochloride capsule
    Product Information
    Item Code (Source) NDC:47682-182
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color pink (PINK) , white (WHITE) Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code CPC;835
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-182-46 1 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 08/25/2010
    Part 5 of 7
    MEDIQUE APAP EXTRA STRENGTH  
    acetaminophen tablet, film coated
    Product Information
    Item Code (Source) NDC:47682-175
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSPOVIDONE (UNII: 68401960MK)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color white (WHITE) Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code AZ;235
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-175-46 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 08/26/2010
    Part 6 of 7
    ASPIRIN  
    aspirin tablet
    Product Information
    Item Code (Source) NDC:52124-0011
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 44;157;ASPIRIN
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0011-1 2 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 08/26/2010
    Part 7 of 7
    ANTISEPTIC TOWELETTE  
    benzalkonium chloride swab
    Product Information
    Item Code (Source) NDC:52124-0001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.40 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0001-1 0.8 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333E 09/09/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333B 08/26/2010
    Labeler - Tender Corp dba Adventure Medical Kits (064437304)
    Registrant - GFA Production (Xiamen) Co., Ltd. (421256261)
    Establishment
    Name Address ID/FEI Business Operations
    GFA Production (Xiamen) Co., Ltd. 421256261 manufacture
    Close

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