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
Close - PURPOSE
- WARNINGS
- 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.
Close - STOP USE
Stop use and consult a doctor:
if the condition persists or gets worse; a rash or other allergic reaction develops
Close - KEEP OUT OF REACH OF CHILDREN
- 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
Close - STORAGE AND HANDLING
- 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.
Close - ACTIVE INGREDIENT
Active Ingredient: Purpose:
Benzocaine, 6% w/v.................. Topical Anesthetic
SD alcohol, 60% w/v.................. Antiseptic
Close - PURPOSE
Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.
Close - WARNINGS
Warnings: For external use only.
Avoid contact with eyes. If this happens, rinse thoroughly with water.
Close - 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 - STORAGE AND HANDLING
- 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.
Close - DESCRIPTION
- PRINCIPAL DISPLAY PANEL
Insect Sting Relief Pad
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
Close - ACTIVE INGREDIENT
Active ingredient (in each tablet) Purpose
Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
Close - 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
Close - 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
Close - 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.
Close - 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
Close - 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
Close - WHEN USING
- 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
Close - 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.
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 - 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. - 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
Close - 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.
Close - DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
Active Ingredient (in each tablet) Purpose
Aspirin (NSAID*) 325 mg............................... Pain Reliever / fever reducer
*nonsteroidal anti-inflammatory drug
Close - PURPOSE
Uses Temporarily relieves minor aches and pains associated with:
Close
headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever - 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:
Close
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 - 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
Close - 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
Close - WHEN USING
- 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
Close - 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
- 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.
Close - 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
Close - INACTIVE INGREDIENT
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
Active Ingredient (in each tablet) Purpose
Acetaminophen 500 mg............................... Pain Reliever / fever reducer
- PURPOSE
- INDICATIONS & USAGE
Uses for the temporary relief of minor aches and pains associated with
Close
headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever - 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.
Close - 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.
Close
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor - ASK DOCTOR
- 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
Close
symptoms do not improve
new symptoms occur
pain or fever persists or gets worse
redness or swellign is present - 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
Close - PREGNANCY OR BREAST FEEDING
- 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:
Close
do not give to children under 12 years of age. - 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
Close - 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*.
Close - ACTIVE INGREDIENT
Active Ingredient (in each tablet) Purpose
Diphenhydramine Hydrochloride 25mg............................... Antihistimine
- PURPOSE
- INDICATIONS & USAGE
Uses Temporarily relieves the following symptoms associated with hay fever or other upper respiratory allergies:
Close
runny nose, sneezing, itching of the nose or throat, itchy, watery eyes - 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
Close - 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 glandif you are:
Close
taking any drugs for asthma
taking sedatives or tranquilizers - 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
Close - 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.
Close - 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:
Close
do not give to children under 12 years of age unless directed by a doctor. - INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.
Close - WARNINGS
- 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
- WHEN USING
Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.
- INACTIVE INGREDIENT
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
Antiseptic Towelette
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
Close - 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 kitProduct 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 8 Part 4 2 PACKET 2 Part 5 3 PACKET 6 Part 6 2 PACKAGE 4 Part 7 10 PACKAGE 8 mL Part 1 of 7 GENUINE TRIPLE ANTIBIOTIC
bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointmentProduct 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 swabProduct 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 tabletProduct 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 capsuleProduct 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 coatedProduct 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 tabletProduct 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 swabProduct 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