Label: MEDIUM CUTS AND SCRATCHES- benzalkonium chloride, water kit

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 7, 2010

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  • 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

  • PRINCIPAL DISPLAY PANEL

    AntisepticTowelette

  • ACTIVE INGREDIENT

    Active Ingredient:

    Purified Water USP...q.s.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Sodium Chloride USP                                          44mg

    Monobasic Sodium Phosphate USP                18mg
    Sodium Phosphate Dibasic USP                       111mg  

    Edetate Disodium USP                                       10mg

    Benzalkonium Chloride                                      0.5mg
    NF (as preservative)

  • STORAGE AND HANDLING

    Store in a cool place. For irrigation only.

    Discard unused portion of the solution.

    Not for injection.

  • WARNINGS

    Warning:

    If you experience eye pain, changes in vision, continued redness or irritation of the eye,

    or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

    Do not use if solution changes color or becomes cloudy.

  • DOSAGE & ADMINISTRATION


    Directions

    Remove contacts before using.

    Twist top to remove.

    Flush the affected area as needed. Control

    Rate of flow by pressure on the bottle. Do not touch

    tip of the container to any surface. Do not reuse.

    If necessary continue flushing with emergency eyewash or shower.

    Discard bottle after use.

  • PURPOSE

    Uses:

    For flushing or irrigating the eyes to

    remove loose foreign material, air pollutants,

    or chlorinated water.

  • DESCRIPTION

    Code No.: GUJ/DRUG/G/1080

    Batch No.:

    Mfg Date:

    Exp: Date:

  • PRINCIPAL DISPLAY PANEL

    10ml

    Sterile Isotonic Buffered Genuine

     Eyewash

    For single use only

  • PRINCIPAL DISPLAY PANEL

    eyewash10ml

  • PRINCIPAL DISPLAY PANEL

    Medium Cuts, Burns and Severe Bleeding

    5 Antiseptic Towelette
    2 Sterile Gauge Pad 2"x2"
    2 Sterile Gauge Pad 3"x3"
    2 Sterile Gauge Pad 4"x4"
    1 Roller Gauge Bandage 2"x4.1 yds.
    1 Sterile Eye Pad
    1 Sterile Eye Wash 10ml
    2 Butterfly Wound Closures

    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

    Medium Cuts and Burns

  • INGREDIENTS AND APPEARANCE
    MEDIUM CUTS AND SCRATCHES 
    benzalkonium chloride, water kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0117
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0117-11 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 15 PACKAGE 4 mL
    Part 21 BOTTLE 10 mL
    Part 1 of 2
    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 finalpart33304/23/2010
    Part 2 of 2
    STERILE ISOTONIC BUFFERED GENUINE EYEWASH 
    water liquid
    Product Information
    Item Code (Source)NDC:52124-0005
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.16 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0005-110 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34504/23/2010
    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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