Label: CARE ONE ANTIBACTERIAL TANGERINE SPICE- alcohol liquid

  • NDC Code(s): 41520-470-02
  • 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

    ETHYL ALCOHOL 65%

    PURPOSE

    ANTISEPTIC

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  • USES

    TO DECREASE BACTERIA ON THE SKIN.

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  • WARNINGS

    FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE.

    WHEN USING THIS PRODUCT

    STOP USE AND ASK A DOCTOR IF

    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

    WET ANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

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  • OTHER INFORMATION

    STORE AT A TEMPERATURE BELOW 110F (43C).

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  • INACTIVE INGREDIENTS:

    WATER (AQUA), pROPYLENE GLYCOL, CARBOMER, GLYCERIN, ISOPROPYL MYRISTATE, FRAGRANCE (PARFUM), AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, TRIETHYL CITRATE, MICA, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, TALC, TITANIUM DIOXIDE, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), RED 4 (CI 14700), ORANGE 4 (CI 15510).

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  • INGREDIENTS AND APPEARANCE
    CARE ONE  ANTIBACTERIAL TANGERINE SPICE
    ethyl alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-470
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 650 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    MICA (UNII: V8A1AW0880)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-470-02 59 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 09/25/2012
    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(41520-470)
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