Label: EMERGENCY PREPAREDNESS- benzalkonium chloride,bacitracin zinc,neomycin sulfate,polymyxin b sulfate, ethyl alcohol kit

  • 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 June 2, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Ethyl Alcohol 62 %
  • PURPOSE


    Uses: For hand washing to decrease bacteria on the skin
  • WARNINGS

    Warnings:

    For external use only

    Flammable, keep away from fire or flame

  • DO NOT USE


    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
  • STOP USE


    Stop use and consult a doctor if irritation and redness develop and persist for more than 72 hours.
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use.
  • STORAGE AND HANDLING

    Other Information: Store at 15 to 25 degree Celsius  (59 to 77 degree Fahrenheit)

  • PRINCIPAL DISPLAY PANEL



    Genuine Hand Sanitizer

    Instant Gel

    Antiseptic Handwash

    with Vitamin E and Aloe

    Kills 99.9 percent of germs

    Without Water


    Net Wt 0.9g (1/32 oz)

    Manufactured in China For

    Genuine First Aid

  • PRINCIPAL DISPLAY PANEL

    Genuine Hand Sanitizer


  • 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

    GENUINE FIRST AID

  • PRINCIPAL DISPLAY PANEL

    AntisepticTowelette

  • 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.

  • PRINCIPAL DISPLAY PANEL

    GenuineTripleAntibiotic
  • PRINCIPAL DISPLAY PANEL

    Emergency Preparedness

    2 Procedural Masks, 3 ply

    1 Emergency Blanket 38" x 60"

    1 Light Stick

    4 Antiseptic Towelettes

    1 Triple Antibiotic Ointment 0.9 gr

    1 Hand Sanitizer 0.9 gr

    Manufactured in China for:

    Genuine First Aid LLC.
    600 Cleveland Street
    Suite 400
    Clearwater FL 33755

    www.GenuineFirstAid.com

    GENUINE FIRST AID

    Copyright 2009 Genuine First Aid LLC.  All rights reserved.

  • PRINCIPAL DISPLAY PANEL

    Emergency Preparedness Kit

  • INGREDIENTS AND APPEARANCE
    EMERGENCY PREPAREDNESS 
    benzalkonium chloride,bacitracin zinc,neomycin sulfate,polymyxin b sulfate, ethyl alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0115
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0115-11 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKAGE 0.9 g
    Part 24 PACKAGE 3.2 mL
    Part 31 PACKAGE 0.5 g
    Part 1 of 3
    GENUINE HAND SANITIZER  
    alcohol gel
    Product Information
    Item Code (Source)NDC:52124-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0006-10.9 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/23/2010
    Part 2 of 3
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    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 CHLORIDE0.40 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0001-10.8 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34504/23/2010
    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
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0003-10.5 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/24/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/23/2010
    Labeler - Genuine First Aid LLC (619609857)
    Establishment
    NameAddressID/FEIBusiness Operations
    GFA Production ( Xiamen) Co., Ltd 421256261manufacture
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