Label: GFA FIRST AID- benzalkonium chloride, benzalkonium chloride, lidocaine, bacitracin zinc, neomycin sulfate, polymyxin b kit

  • Category: HUMAN OTC DRUG LABEL

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

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  • Active Ingredient

    Active Ingredient:                        

    Benzalkonium Chloride 0.40%

  • Purpose


    Antiseptic
  • 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.

  • Directions

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


  • Inactive Ingredients

    Inactive Ingredient:   Purified water


  • SPL UNCLASSIFIED SECTION

    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 Ingredients

    ACTIVE INGREDIENTS:

    Benzalkonium Chloride 0.13%
    Lidocaine HCL 0.5%


  • Purpose

    Purpose: First aid antiseptic, external analgesic


  • Uses

    First aid to help prevent infection and for the temporary relief of pain and itching associated with:

    Minor Cuts

    Scrapes

    Burns

  • Warnings


    For external  use only



  • DO NOT USE

    Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week

    Do not use:
    in the eyes or apply over large areas of the body.
    longer than 1 week unless directed by a doctor.
    in large quantities, particularly over raw surfaces or blistered areas.

    Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.

    When using this product, avoid contact with the eyes.
  • STOP USE


    Stop use and ask a doctor if
    condition worsens
    symptoms persist for more than 7 days
    condition clears up and occurs again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children.

    If ingested, contact a Poison Control Center right away.

  • Directions



    Adults and children 2 years of age and older

    clean affected area.

    apply a small amount of this product on the area 1 to 3 times daily.

    may be covered with a sterile bandage

    children under 2 years of age: consult a doctor

  • STORAGE AND HANDLING

    Other Information:

    Store at room temperature (do not freeze).

    Taper evident sealed packets.

    Do not use packet if opened or torn.

  • Inactive Ingredients

    Aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, irolamine

  • DESCRIPTION

    LOT/EXP:                                    Made in CHINA

    20130301



    GFA Production Xiamen Co., Ltd
    No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100
    Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com

  • PRINCIPAL DISPLAY PANEL

    Genuine First Aid Burn Cream

    Antiseptic Pain Relief With Aloe

    Net Wt 0.9g (1/32 oz)

    Manufactured in CHINA for

    Genuine First Aid.

  • Active Ingredients

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

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

    Polymyxin B Sulfate 5000 units

  • Purpose

    Triple Antibiotic

  • INDICATIONS & USAGE

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

  • 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.

  • 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

  • STORAGE AND HANDLING

    Other information:

    Store at room temperature.

  • Inactive Ingredient

    water
  • 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

  • PRINCIPAL DISPLAY PANEL

    Genuine Triple Antibiotic

  • PRINCIPAL DISPLAY PANEL

    Genuine Triple Antibiotic

  • PRINCIPAL DISPLAY PANEL

    Burn Cream

  • PRINCIPAL DISPLAY PANEL

    Burn Cream

  • PRINCIPAL DISPLAY PANEL

    Antiseptic Towelette

  • PRINCIPAL DISPLAY PANEL

    Antiseptic Towelette

  • PRINCIPAL DISPLAY PANEL

    GFA First Aid Kit

  • PRINCIPAL DISPLAY PANEL

    GFA First Aid Kit

  • INGREDIENTS AND APPEARANCE
    GFA FIRST AID 
    benzalkonium chloride, benzalkonium chloride, lidocaine, bacitracin zinc, neomycin sulfate, polymyxin b kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-1164
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-1164-31 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 PACKET 8.0 mL
    Part 26 PACKET 5.4 g
    Part 310 TUBE 5.0 g
    Part 1 of 3
    ANTISEPTIC TOWELETTE  
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:52124-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0001-21 in 1 BOX
    10.8 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/07/2011
    Part 2 of 3
    GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE 
    benzalkonium chloride, lidocaine cream
    Product Information
    Item Code (Source)NDC:52124-0004
    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 (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0004-26 in 1 BOX
    10.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333A04/13/2011
    Part 3 of 3
    GENUINE TRIPLE ANTIBIOTIC 
    bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
    Product Information
    Item Code (Source)NDC:52124-0003
    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 SULFATE5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0003-210 in 1 BOX
    10.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/13/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E04/13/2011
    Labeler - Genuine First Aid, LLC (619609857)