Label: CARE ONE ANTIBACTERIAL PEPPERMINT SWIRL- triclosan liquid

  • NDC Code(s): 41520-193-08
  • Packager: AMERICAN SALES COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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  • ACTIVE INGREDIENT

    PURPOSE

    ANTIBACTERIAL

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  • USES

    FOR WASHING TO DECREASE BACTERIA ON THE SKIN.

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  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    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.

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  • DIRECTIONS

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

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  • INACTIVE INGREDIENTS:

    WATER (AQUA), SODIUM LAURETH SULFATE, DISODIUM LAURETH SULFOCCINATE, COCAMIDOPROPYLAMINE OXIDE, GLYCERIN, SODIUM CHLORIDE, PEG-7 GLYCERYL COCOATE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, TETRASODIUM EDTA, PROPYLENE GLYCOL, POLYSORBATE 60, ALOE BARBADENSIS LEAF JUICE, BENZOPHENONE-4, HYDROXYPROPYL METHYLCELLULOSE, RED 33 (CI 17200), RED 4 (CI 14700), BLUE 1 (CI 42090), METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE.

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  • INGREDIENTS AND APPEARANCE
    CARE ONE  ANTIBACTERIAL PEPPERMINT SWIRL
    triclosan liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-193
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURETH SULFATE  
    DISODIUM LAURETH SULFOSUCCINATE  
    COCAMIDOPROPYLAMINE OXIDE  
    GLYCERIN  
    SODIUM CHLORIDE  
    PEG-7 GLYCERYL COCOATE  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)  
    EDETATE SODIUM  
    PROPYLENE GLYCOL  
    POLYSORBATE 60  
    ALOE VERA LEAF  
    SULISOBENZONE  
    HYPROMELLOSES  
    D&C RED NO. 33  
    FD&C RED NO. 4  
    FD&C BLUE NO. 1  
    METHYLCHLOROISOTHIAZOLINONE  
    METHYLISOTHIAZOLINONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-193-08 237 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 09/27/2012
    Labeler - AMERICAN SALES COMPANY (809183973)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    Name Address ID/FEI Business Operations
    APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(41520-193)
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