Label: AFIA FOAMING ANTI-BACTERIAL HAND CLEANER- chloroxylenol soap

  • NDC Code(s): 71023-446-57
  • Packager: National Chemical Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 10, 2016

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  • Drug Facts

    Active Ingredient. Purpose

    Chloroxylenol 0.3%............Antimicrobial

    Active Ingredient. Purpose Chloroxylenol 0.3%............Antimicrobial

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  • Uses

    For hand washing to decrease bacteria on the skin

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  • Warnings:

    For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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  • Directions

    • Wet a hand. Pump one or two stokes of foam, into palm of hand.
    • Rub thoroughly over all surfacesof both hands for 30 seconds
    • Rinse hands and dry thoroughly.
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  • Inactive ingredients

    Water, Sodium Methyl 2-Sulfolaurate, Disodium 2-Sulfolaurate, Decyl glucoside, Cocamidopropyl Betaine, Lauric Monoethanolamide, Cetrimonium Chloride, PEG-150 Distearate, Phenoxyethanol, fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C yellow #5, FD&C blue #1

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  • Warnings:

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Uses

    For hand washing to decrease bacteria on the skin

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  • INGREDIENTS AND APPEARANCE
    AFIA FOAMING ANTI-BACTERIAL HAND CLEANER 
    chloroxylenol soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71023-446
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    LAURIC MONOETHANOLAMIDE (UNII: 098P2IGT76)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71023-446-57 1000 mL in 1 BAG; Type 0: Not a Combination Product 10/24/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 10/24/2016
    Labeler - National Chemical Laboratories, Inc. (002289619)
    Registrant - National Chemical Laboratories, Inc. (002289619)
    Establishment
    Name Address ID/FEI Business Operations
    National Chemical Laboratories, Inc. 002289619 manufacture(71023-446)
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