GFA FIRST AID (BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) KIT [GENUINE FIRST AID, LLC]

GFA FIRST AID (BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) KIT [GENUINE FIRST AID, LLC]
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NDC 52124-0001-2, 52124-0003-2, 52124-0004-2, 52124-1165-3
Set ID 6e5b59bc-c5b4-4ae7-8956-7d515e1d7b0b
Category HUMAN OTC DRUG LABEL
Packager Genuine First Aid, LLC
Generic Name
Product Class Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic
Product Number
Application Number PART333E
  • 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  16 UNIT METAL CASE
    benzalkonium chloride, benzalkonium chloride, lidocaine, bacitracin zinc, neomycin sulfate, polymyxin b kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-1165
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-1165-31 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:52124-0001-210 in 1 BOX
    10.8 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/03/2011
    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 finalpart333E05/03/2011
    Labeler - Genuine First Aid, LLC (619609857)

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