Label: ANTIMICROBIAL FOAM- tricolsan soap

  • 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 December 4, 2012

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  • Antimicrobial Foam

    ​Active Ingredient

    ​ ​Triclosan 0.30%

  • Antimicrobial Foam

    Uses

    • ​​Antibacterial hand cleaner.
    • Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices.
  • Antimicrobial Foam

    Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.
  • Antimicrobial Foam

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 0.8 mL of product onto wet palm.
    • Rub hands together to distribute product, then rinse hands with clean.
  • Antimicrobial Foam

    Inactive Ingredients

    ​Water, Potasium cocoate (contains coconut), Propylene Glycol, Glycerine, DMDM Hydantoin, Fragrance, FD&C Yellow #5, Aloe Barbadensis Leaf Juice. FD&C Red #40.

  • Antimicrobial Foam

    Purpose

    ​Antibacterial

  • Antimicrobial Foam

    KEEP OUT OF REACH OF CHILDREN

  • Antimicrobial Foam

    AFFEX CLEANING SOLUTIONS

    Antimicrobial Foam Soap

    Foaming Skin Cleanser with Triclosan

    MEDICAL EMERGENCY:

    (800)424-9300

    NET CONTENTS: 1000 mL

    ITEM #305-60

    Afflink 305.jpg

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL FOAM 
    tricolsan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54057-305
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALOE VERA Leaf (UNII: ZY81Z83H0X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54057-305-601000 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/12/2012
    Labeler - Afflink, Inc. (023121150)
    Registrant - Betco Corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corpo, Ltd.005050158manufacture(54057-305) , label(54057-305) , pack(54057-305)
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