Label: CARE ONE ANTIBACTERIAL TANGERINE SPICE- triclosan liquid

  • Category: HUMAN OTC DRUG LABEL

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 September 27, 2012

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.3%

    PURPOSE

    ANTIBACTERIAL

  • USES

    FOR WASHING TO DECREASE BACTERIA ON THE SKIN.

  • WARNINGS

    STOP USING THIS PRODUCT AND ASK DOCTOR

    KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    APPLY TO DRY HANDS, WORK INTO A RICH FOAMY LATHER AND RINSE THOROUGHLY.

  • INACTIVE INGREDIENT

    WATER, SODIUM XYLENESULFONATE, GLYCERIN, DIPROPYLENE GLYCOL, COCAMIDOPROPYL BETAINE, SODIUM LAURETH SULFATE, DISODIUM PHOSPHATE, FRAGRANCE (PARFUM), METHYLPARABEN, PROPYLPARABEN, POLYSORBATE-20, SODIUM PCA, POLYQUATERNIUM-10, TOCOPHERYL ACETATE, CITRIC ACID, CETYL ALCOHOL, RED 33 (CI 17200), ORANGE 4 (CI 15510).

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    CARE ONE  ANTIBACTERIAL TANGERINE SPICE
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER BUFFALO (UNII: 0A4PW6CRAI)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-191-08237 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/27/2012
    Labeler - AMERICAN SALES COMPANY (809183973)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41520-191)
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