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GFA First Aid Kit Essentials - 33 Pieces (Genuine First Aid, LLC)

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Dosage Form Package Information Links
KIT 1 KIT in 1 KIT (52124-1023-6) * .5 g in 1 TUBE (52124-0003-1) * 2 TABLET in 1 PACKET (52124-0009-1) * 2 TABLET in 1 PACKAGE (52124-0010-1) * .5 mL in 1 PACKAGE (52124-0002-1) * 2 TABLET in 1 PACKAGE (52124-0011-1) * .8 mL in 1 PACKAGE (52124-0001-1) Label Information

Complete GFA First Aid Kit Essentials - 33 Pieces Information

  • ACTIVE INGREDIENT

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

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

    Polymyxin B Sulfate 5000 units


  • PURPOSE

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


  • WARNINGS

    Warnings:

    For external use only.


  • 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.


  • STOP USE

    Stop use and consult a doctor:

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


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If ingested, contact a Poison

    Control Center right away.


  • 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


  • STORAGE AND HANDLING

    Other information:

    Store at room temperature.


  • 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.


  • ACTIVE INGREDIENT


    Active ingredient (in each tablet)                       Purpose

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

    *nonsteroidal anti-inflammatory drug


  • 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

  • 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

  • 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.


  • 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

  • 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

  • WHEN USING

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

  • 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

  • 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.

  • 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.

  • 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

  • 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.


  • DESCRIPTION

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


  • PRINCIPAL DISPLAY PANEL

    IBUPROFEN 2 Tablets


  • PRINCIPAL DISPLAY PANEL

    IBUPROFEN   2 Tablets


  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)                      Purpose

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

    *nonsteroidal anti-inflammatory drug 


  • 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


  • 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


  • 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


  • 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


  • 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


  • WHEN USING

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


  • 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

  • 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.


  • 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.


  • 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.


  • 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


  • INACTIVE INGREDIENT

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


  • DESCRIPTION

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

  • PRINCIPAL DISPLAY PANEL

    ASPIRIN 2 Tablets

  • ACTIVE INGREDIENT

    Active Ingredient:                                 Purpose

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


  • PURPOSE

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


  • WARNINGS

    Warning:   For external use only.


  • 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.


  • STOP USE

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


  • DO NOT USE

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


  • WHEN USING

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



  • INACTIVE INGREDIENT

    Inactive Ingredient:   Purified water



  • DESCRIPTION

    LOT/EXP:                           Made in CHINA

    20130301


  • PRINCIPAL DISPLAY PANEL

    Antiseptic Towelette

    Genuine First Aid LLC, Clearwater FL 33755

    www.GenuineFirstAid.com

    1/pouch

    GENUINE FIRST AID


  • Active Ingredient (in each tablet)

    Acetaminophen 325 mg


  • Purpose

    Analgesic/antipyretic
  • Uses


    temporary relief of minor aches and pains associated with:

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


  • 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


  • 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


  • ASK DOCTOR

    Ask a doctor before use if the user has liver disease


  • ASK DOCTOR/PHARMACIST

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


  • 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


  • PREGNANCY OR BREAST FEEDING

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


  • 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


  • Inactive Ingredients

    Cornstarch, polyethylene glycol, stearic acid, povidone


  • 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.


  • STORAGE AND HANDLING

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



  • GENERAL PRECAUTIONS

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


  • DESCRIPTION

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

  • PRINCIPAL DISPLAY PANEL

    GENUINE FIRST AID         2 Tablets

    NON-ASPIRIN


  • Active Ingredient

    Active Ingredient:                                

    Isopropyl Alcohol, 70% v/v


  • Purpose

    Antiseptic


  • Use

     For preparation of skin before injection.


  • Warnings

     For external use only.  


  • STORAGE AND HANDLING

    Flammable - keep away from fire or flame

    Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)


  • DO NOT USE

    Do not use: with electrocautery, in the eyes.


  • STOP USE

    Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.


  • 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.


  • Directions

    Wipe Injection site vigorously and discard.

  • Inactive Ingredient

    Purified water.


  • SPL UNCLASSIFIED SECTION

    LOT/EXP:            Made in CHINA

    20140301


  • PRINCIPAL DISPLAY PANEL

    Alcohol Cleansing Pad

    Genuine First Aid LLC, Clearwater FL 33755

    www.GenuineFirstAid.com

    1/pouch

    GENUINE FIRST AID




    100 Alcohol cleansing pads

    Reorder GFAP-39-02


  • INGREDIENTS AND APPEARANCE
    GFA FIRST AID KIT ESSENTIALS - 33 PIECES 
    aspirin, ibuprofen, acetaminophen, alcohol, benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-1023
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-1023-6 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 2 TUBE 1 g
    Part 2 2 PACKET
    Part 3 2 PACKAGE
    Part 4 3 PACKAGE 1.5 mL
    Part 5 2 PACKAGE
    Part 6 3 PACKAGE 2.4 mL
    Part 1 of 6
    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 08/18/2011
    Part 2 of 6
    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 08/18/2011
    Part 3 of 6
    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 08/18/2011
    Part 4 of 6
    ALCOHOL CLEANSING PAD 
    isopropyl alcohol liquid
    Product Information
    Item Code (Source) NDC:52124-0002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 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:52124-0002-1 0.5 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 08/18/2011
    Part 5 of 6
    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 08/18/2011
    Part 6 of 6
    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 08/18/2011
    Labeler - Genuine First Aid, LLC (619609857)
    Registrant - GFA Production (Xiamen) Co., Ltd. (421256261)
    Establishment
    Name Address ID/FEI Business Operations
    GFA Production (Xiamen) Co., Ltd. 421256261 manufacture