READY CARE XL KIT (FIRST AID KIT) KIT [DUKAL CORPORATION]

READY CARE XL KIT (FIRST AID KIT) KIT [DUKAL CORPORATION]
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NDC 47682-088-99, 47682-116-99, 47682-145-99, 59898-740-01, 59898-902-01, 65517-0001-1, 65517-0004-1, 65517-0021-1
Set ID 817e2a80-6d90-42ea-9e85-8daa170f231c
Category MEDICAL DEVICE
Packager Dukal Corporation
Generic Name
Product Class Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic
Product Number
Application Number PART333
  • PRINCIPAL DISPLAY PANEL

    Physicians Care

    FIRST AID

    50 Person

    ReadyCare XL Kit

    Contains over 355 Pieces


  • Back Label

    Physicians Care

    CLEANSE

    20    Antiseptic Wipes
    20    Alcohol Pads

    TREAT

     6     Antibiotic Ointment Packets
     6     Burn Ointment Packets
    10    3" Cotton Tip Applicators

    PROTECT

    3       Knuckle Bandages
    3       Fingertip Bandages
    35     3/8” x 1 1/2” Bandages
    16     1” x 3” Bandages
    200   3/4” x 3” Bandages
    1      1/2" Tape
    1      Triangular Bandage
    4      3" x 3" Sterile Gauze Pads
    1      Abdominal Compress

    Medicine

    3     Acetaminophen Packets (packet of 2)
    3     Aspirin Packets (packets of 2)
    3     Antacid Packets (packets of 2)

    Other

    Gloves (2 Pair)
    1       Cold Pack
    1       First Aid Guide
    10     Finger Splints
    5       Disposable Thermometers
    1       Tweezer


    Acme United Corporation
    60 Round Hill Road
    Fairfield CT 06824

    www.acmeunited.com

    Designed in the USA | Made in China

    CAUTION: This product may contain natural
    rubber latex which may cause allergic reactions.
    This kit contains products that have expiration dates. Please check before use.

  • BZK Towelette Labeling

    Reorder 855

    NDC 65517-0004-1

    Dukal

    BZK TOWELETTE

    Contains Benzalkonium Chloride

    For External Use Only

    Helps Prevent Infection

    1 / Pouch

    DUKAL CORPORATION

    (631) 656-3800

    Ronkonkoma, NY 11779 www.dukal.com

    Made in China


    Drug Facts

    Active Ingredients....................Benzalkonium Chloride 0.133% w/v

    Purpose................................. First Aid Antiseptic

    USE: Antiseptic Cleansing of face, hands and
    body without soap and water. Airs dries in seconds

    DO NOT USE: in the eyes or apply over large
    areas of the body.

    STOP USE: If irritation, redness or other symptoms
    develop. Consult a doctor if the conditions persists
    or gets worse.

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

    DIRECTIONS: Tear open packet, unfold and use
    as a washcloth.

    INACTIVE INGREDIENTS: Distilled Water


  • Prep Pad Labeling

    Reorder 852

    Dukal Corporation

    NDC 65517-0001-1

    NPN 80003156

    ALCOHOL PREP PAD

    Saturated with 70% Isopropyl Alcohol

    For External Use Only

    1 / Pouch

    Dukal Corporation

    Ronkonkoma, NY 11779

    631-656-3800

    www.dukal.com

    Made in China


    Drug Facts

    Active Ingredients

    Isopropyl Alcohol 70%

    Purpose

    Antiseptic Cleanser

    Use

    For Preparation of Skin prior to an injection

    Warnings

    • For External Use Only
    • Flammable, Keep away from fire or flame

    Do Not Use

    • with electrocautery procedures
    • In the Eyes. If contact occurs, flush eyes with water

    Stop Use

    If irritation and redness develop. If condition persists, consult your health care practitioner.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    Wipe injection site vigorously and discard.

    Other Information

    Store at Room Temperature 15 - 30 C (59 - 86 F)

    Inactive Ingredient

    purified water
  • Triple Antibiotic Labeling

    WaterJel

    Triple Antibiotic

    First Aid Ointment

    To Help Prevent Infection

    Each Gram contains

    Bacitracin Zinc 400 units

    Neomycin Sulphate 5 mg

    (equivalent to 3.5 mg Neomycin base)

    Polymyxin B Sulfate 5000 units

    Water-Jel Technologies

    Carlstadt, NJ 07072

    Drug Facts

    Uses to help prevent infection in

    minor cuts, scrapes, burns

    Warnings

    For external use only

    Do not use

    in the eyes or apply over large areas of the body

    If you are allergic to any of the ingredients

    longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    the condition persists or gets worse

    a rash or other allergic reaction develops

    Keep out of reach of children

    if ingested contact Poison Control Center right away

    Directions

    clean affected area apply a small amount of 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

  • First Aid Burn Cream Labeling

    WaterJel

    First Aid Burn Cream

    Antiseptic Pain Relief with Aloe

    Active Ingredients:

    Benzalkonium Chloride 0.13%

    Lidocaine HCL 0.5%

    Water-Jel Technologies

    Carlstadt, NJ 07072

    Drug Facts

    Purpose

    First Aid Antiseptic, External analgesic

    Uses

    first aid to help prevent infection and for temporary

    relief of pain an itching associated with minor cuts,

    scrapes, burns

    Warnings

    For external use only

    Do not use

    in the eyes

    in large quantities over raw or blistered areas or on

    deep puncture wounds, animal bites, or serious burns

    Keep out of reach of children

    if ingested contact Poison Control Center right away

    Directions

    clean affected area apply a small amount not more

    than 3 times daily may be covered with a sterile bandage

    Other Information

    Store at room temperature

  • APAP Labeling

    Drug Facts
    Active Ingredients (In each tablet)...............Purposes
    Acetaminophen 325 mg.............................Pain Reliever/Fever Reducer
    Uses:
    For the temporary relief of minor aches and pains associated with:
    • headache • muscular aches • minor arthritis pain
    • common cold • toothache • menstrual cramps
    For the reduction of fever.
    Warnings:
    Alcohol Warning: If you consume 3 or more alcoholic drinks every day,
    ask your doctor whether you should take acetaminophen or other pain
    relievers/fever reducers. Acetaminophen may cause liver damage.
    Do not use:
    • with any other product containing acetaminophen
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor
    Stop Using and Ask a Doctor If:
    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse
    • redness or swelling is present
    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 Poison Control Center immediately.
    Prompt medical attention is critical for adults as well as for children even if you do not notice
    any signs or symptoms.
    If pregnant or breast feeding, ask a health professional before use.
    Directions:
    Do not use more than directed
    Adults and children: (12 years and older)
    Take 2 tablets 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.
    Other Information:
    • Store at room temperature
    • Tamper-Evident Sealed Packets
    • Do Not Use any Opened or Torn Packets
    Inactive Ingredients:
    Corn starch*, croscarmellose sodium, crospovidone, hypromellose, microcrystalline cellulose,
    mineral oil, opadry clear, pharmaceutical glaze, polyethylene glycol, povidone*, pregelatinized
    starch*, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid*, talc*, titanium dioxide.
    *may contain
    Questions or comments? 1-800-634-7680

  • Alcalak Labeling

    Drug Facts
    Active Ingredients (In each tablet)....................Purposes
    Calcium Carbonate 420 mg ..............................Antacid
    Uses:
    For the relief of the following symptoms associated with:
    • acid indigestion • sour stomach • heartburn • upset stomach
    Warnings:
    Ask a doctor or health professional before use if you have:
    • been taking a prescription drug. Antacids may interact with certain prescription drugs.
    • kidney stones
    • a calcium-restricted diet
    Stop using this product and ask a doctor if:
    • symptoms last more than 2 weeks
    Do not exceed recommended dosage.
    Keep this and all drugs out of the reach of children. If you are pregnant or breast feeding,
    ask a health professional before use.
    Directions:
    • Do not use more than directed
    Adults and children: (12 years and older)   
    Take 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not
    take more than 19 tablets in a 24 hour period, or use the maximum dosage of this product for
    more than 2 weeks, except under the advice and supervision of a physician.
    Children under 12 years:   
    Do not give to children under 12 years of age.
    Other Information:
    • Phenylketonurics: Contains Phenylalanine 1.5 mg per tablet
    • Each tablet contains 168 mg of elemental calcium
    • Store at room temperature in a dry place
    • Tamper-Evident Sealed Packets
    • Do not Use any Opened or Torn Packets
    Inactive Ingredients:
    aspartame*, carageenan*, croscarmellose sodium*, glycine*, magnesium stearate, mint flavor*,
    silica*, sorbitol, spearmint flavor*, stearic acid*, stevix*, xylitol*  
    *may contain
    Questions or comments? 1-800-634-7680

  • Aspirin Labeling

    Drug Facts
    Active Ingredients (In each tablet)..................Purposes
    Aspirin 325mg (NSAID*) ...............................Pain Reliever / Fever Reducer
    *nonsteroidal anti-inflammatory drug
    Uses:
    Temporarily relieves minor aches and pains due:
    • headache • muscular aches • minor arthritis pain • backache
    • common cold • toothache • menstrual cramps
    Temporarily reduces fever.
    Warnings:
    Reye's Syndrome: Children and teenagers should not use this medicine for chicken pox,
    or flu symptoms before a doctor is consulted about Reye's Syndrome, a rare but serious
    illness reported to be associated with aspirin.
    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 product contains a nonsteroidal anti-inflammatory
    drug (NSAID), which may cause stomach bleeding.
    The chance is higher if you:
    • are age 60 or older • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcohol drinks every day while using this product
    • take more or for a longer time than directed
    Do not use:
    • if you have ever had an allergic reaction to any other pain reliever/ fever reducer.
    • right before or after heart surgery
    Ask a Doctor before use if you have:
    • problems or serious side effects from taking pain relievers or fever reducers
    • stomach problems that last or come back, such as heartburn, upset stomach, or
    stomach pain • ulcers • bleeding problems • high blood pressure
    • heart or kidney disease • taken a diuretic • reached age 60 or older
    Ask a Doctor or Pharmacist before use if you are:
    • taking any other drug containing and NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) or steroid drug
    • under a doctor’s care for any serious condition • taking any other drug
    When using this product:
    • take with food or milk if stomach upset occurs
    • long term continuous use may increase the risk of heart attack or stroke
    Stop Using and Ask a Doctor If:
    • you feel faint, vomit blood, or have bloody or black stools. These are signs of
    stomach bleeding. • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days • you have difficulty swallowing
    • it feels like the pill is stuck in your throat • you develop heartburn
    • stomach pain or upset gets worse or lasts
    • redness or swelling is present in the painful area • any new symptoms appear
    If pregnant or breast-feeding, ask a health professional before use. It is especially
    important not 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.
    Keep out of reach of children. In case of overdose, get medical help or contact a
    Poison Control Center right away.
    Directions:
    • Do not take more than directed.
    • The smallest effective dose should be used.
    • Do not take longer than 10 days, unless directed by a doctor (see Warnings)
    • Drink a full glass of water with each dose.
    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.
    Other Information:
    • Read all product information before using
    • Store at room temperature
    • Avoid excessive heat and humidity
    • Tamper evident sealed packets
    • Do not use any opened or torn packets
    Inactive Ingredients:
    Corn starch, croscarmellose sodium*, hypromellose*, microcrystalline cellulose*, mineral oil*,
    polyethylene glycol, propylene glycol, silicon dioxide, starch, stearic acid, talc, titanium dioxide*.
    *may contain
    Questions or comments? 1-800-634-7680

  • Ready Care XL Kit Label

    Front Label

  • Ready Care XL Kit Back Label

    Back Label

  • Prep Pad Labeling

    Prep Pad Label

  • Antiseptic Towelette Label

    BZK Label

  • Antacid Label

    Antacid Label

  • Acetaminophen Label

    APAP Label

  • Aspirin Label

    Aspirin Label

  • Triple Antibiotic Label

    Antibiotic Label

  • Burn Cream Label

    Burn Cream Label

  • INGREDIENTS AND APPEARANCE
    READY CARE XL KIT 
    first aid kit kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NDC:65517-0021
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-0021-11 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 120 POUCH 8.0 mL
    Part 26 PACKET 5.4 g
    Part 36 PACKET 5.4 g
    Part 420 POUCH 28.0 mL
    Part 53 PACKET
    Part 63 PACKET
    Part 73 PACKET
    Part 1 of 7
    DUKAL ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC:65517-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.70 mL  in 1.0 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-0001-10.4 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2000
    Part 2 of 7
    WATER-JEL 3-IN1 ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate and neomycin sulfate ointment
    Product Information
    Item Code (Source)NDC:59898-740
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-740-010.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33301/01/2010
    Part 3 of 7
    FIRST AID BURN 
    lidocaine hydrochloride and benzalkonium chloride cream
    Product Information
    Item Code (Source)NDC:59898-902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-902-010.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33301/01/2010
    Part 4 of 7
    BZK TOWELETTE 
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:65517-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.00186 mL  in 1.4 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 1.39814 mL  in 1.4 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-0004-11.4 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2006
    Part 5 of 7
    MEDIQUE APAP 
    acetaminophen tablet, film coated
    Product Information
    Item Code (Source)NDC:47682-145
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-145-992 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34312/30/2008
    Part 6 of 7
    MEDIQUE ASPIRIN  
    aspirin tablet, film coated
    Product Information
    Item Code (Source)NDC:47682-116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-116-992 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34312/30/2008
    Part 7 of 7
    MEDIQUE ALCALAK 
    calcium carbonate tablet, chewable
    Product Information
    Item Code (Source)NDC:47682-088
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Carbonate (UNII: H0G9379FGK) (Calcium - UNII:SY7Q814VUP) Calcium Carbonate420 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorMINT (MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-088-992 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/30/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33305/01/2010
    Labeler - Dukal Corporation (791014871)