Label: ANTIMICROBIAL FOAMING- benzethonium chloride liquid

  • 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 July 22, 2011

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  • ACTIVE INGREDIENT

    BENZETHONIUM CHLORIDE 0.1 PERCENT

  • PURPOSE

    ANTIMICROBIAL

  • USES

    FOR WASHING TO DECREASE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE WITH WATER.

    STOP USING THIS PRODUCT AND ASK A DOCTOR

    IF IRRITATION OR REDNESS DEVELOPS AND LASTS.

  • DIRECTIONS

    PUMP INTO WET HANDS.  WORK INTO A LATHER VIGOROUSLY.  RINSE THOROUGHLY.

  • INACTIVE INGREDIENTS

    WATER, COCAMIDOPROPYL BETAINE, GLYCERIN, DECYL GLUCOSIDE, POLYQUATERNIUM-7, FRAGRANCE, CAMELLIA SINENSIS, ZINGIBER OFFICINALE, HIBISCUS SABDARIFFA, CHAMOMILA RECUTITA, CITRIC ACID, ORIGANUM VULGARE LEAF EXTRACT, THYMUS VULGARE (THYME) EXTRACT, CINNAMOMUM ZEYLANICUM BARK EXTRACT, ROSEMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) ROOT EXTRACT, TETRASODIUM EDTA, GREEN 5, RED 33, YELLOW 5.

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL FOAMING   FALLING RAIN
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-241
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GINGER (UNII: C5529G5JPQ)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    OREGANO (UNII: 0E5AT8T16U)  
    THYME (UNII: CW657OBU4N)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    ROSEMARY (UNII: IJ67X351P9)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-241-12354 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/22/2011
    Labeler - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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