Label: EASY CARE FIRST AID KIT - SPORTS AND TRAVEL - benzalkonium chloride, benzocaine, sd alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, ibuprofen, acetaminophen

  • NDC Code(s): 44224-0999-5, 52124-0001-1, 52124-0003-1, 52124-0008-1, view more
    52124-0009-1, 52124-0010-1
  • Packager: Tender Corp dba Adventure Medical Kits
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 13, 2011

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Active Ingredient:                        

    Benzalkonium Chloride 0.40%

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  • Purpose


    Antiseptic
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  • 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.

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  • STOP USE

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

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  • DO NOT USE

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

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  • Directions

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


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  • Inactive Ingredients

    Inactive Ingredient:   Purified water


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  • SPL UNCLASSIFIED SECTION

    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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  • 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 Ingredients

    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

    Triple Antibiotic

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  • INDICATIONS & USAGE

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

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  • 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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  • Directions

    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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  • Inactive Ingredient

    water Close
  • 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.



    Triple Antibiotic Ointment 10pcs

    Net wt. 0.9g (1/32oz)



    100
    Triple Antibiotic

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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)            Purpose

    Acetaminophen 325 mg .............            Analgesic/antipyretic

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  • PURPOSE

    Uses

    temporary relief of minor aches and pains associated with:

    common cold;  headache; toothache; muscular aches;  backache; arthritis; menstrual cramps;  and reduction of fever

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  • WARNINGS

    Warnings:

    Liver warning:   This product contains acetaminophen.

    Severe liver damage may occur if:  adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours;  taken with other drugs containing acetaminophen;  adult has 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 nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist;  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 the user has liver disease

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

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  • STOP USE

    Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur;  redness or swelling is present; a rare sensitivity reaction occurs

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of accidental overdose, contact a doctor 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.  Do not exceed recommended dosage

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  • DOSAGE & ADMINISTRATION

    Directions

    Adults and Children                        Take 2 tablets every 4 to 6 hours as

    12 years of age                               needed.  Do not take more than 12 tablets

    or older                                          in 24 hours.



    Children 6-11 years                           Take 1 tablet every 4 to 6 hours as

    of age                                               needed.  Do not take more than 5

                                                            tablets in 24 hours.



    Children under 6                                Do not use this regular strength product.

    years of age                                      This will provide more than the

                                                             recommended dose (overdose) and could

                                                             cause serious health problems.

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  • STORAGE AND HANDLING

    Store at 59-86 degree F (15-30 degree C)


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  • GENERAL PRECAUTIONS

    tamper evident sealed packets; do not use any open or torn packets

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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

    GENUINE FIRST AID         2 Tablets

    NON-ASPIRIN

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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.
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  • 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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  • INGREDIENTS AND APPEARANCE
    EASY CARE FIRST AID KIT - SPORTS AND TRAVEL 
    benzalkonium chloride, benzocaine, sd alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, ibuprofen, acetaminophen kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:44224-0999
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44224-0999-5 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 20 PACKAGE 16 mL
    Part 2 4 PACKAGE 2.0 mL
    Part 3 3 TUBE 1.5 g
    Part 4 4 PACKAGE
    Part 5 2 PACKET
    Part 1 of 5
    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 0.4 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 not final part333E 04/13/2011
    Part 2 of 5
    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 04/13/2011
    Part 3 of 5
    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 0.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 04/13/2011
    Part 4 of 5
    NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:52124-0010
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white (WHITE) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code AZ;234
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0010-1 2 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/13/2011
    Part 5 of 5
    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 02/17/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 04/13/2011
    Labeler - Tender Corp dba Adventure Medical Kits (064437304)
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