Label: CAREONE ANTIMICROBIAL FOAMING HAND SP FALLING RAIN- 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 May 25, 2011

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  • ACTIVE INGREDIENT

    BENZETHONIUM CHLORIDE 0.1 PERCENT

  • PURPOSE

    ANTIBACTERIAL

  • USES

    FOR HAND 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 POISON CONTROL CENTER IMMEDIATELY.

    WHEN USING THIS PRODUCT

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

    STOP USING THIS PRODUCT AND ASK A DOCTOR

    IF IRRITATION OR RASH DEVELOPS AND LASTS.

  • DIRECTIONS

    PUMP ONTO DRY HANDS, WORK INTO A LATHER AND RINSE THOROUGHLY.

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

  • INACTIVE INGREDIENTS

    WATER, COCAMIDOPROPYL BETAINE, GLYCERIN, DECYL GLUCOSIDE, POLYQUATERNIUM-7, POLYSORBATE 20, FRAGRANCE, CAMELLIA SINENSIS LEAF EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, HIBISCUS SABDARIFFA FLOWER EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, CITRIC ACID, ORIGANUM VULGARE LEAF EXTRACT, THYMUS VULGARE (THYME) FLOWER/ LEAF EXTRACT, CINNAMOMUM ZEYLANICUM BARK EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) ROOT EXTRACT, TETRASODIUM EDTA, GREEN 5 (CI 61570), RED 33 (CI 17200), YELLOW 5 (CI 19140).

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF ANTIBACTERIAL FOAMING
  • INGREDIENTS AND APPEARANCE
    CAREONE ANTIMICROBIAL FOAMING HAND SP FALLING RAIN 
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-241
    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)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    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)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-241-08221 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/25/2011
    Labeler - AMERICAN SALES COMPANY (809183973)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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