Label: CARE ONE VANILLA APPLE BLOSSOM- alcohol liquid 

  • NDC Code(s): 41520-476-02
  • 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 02/13

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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 FOM SOURCE OF HEAT OR FIRE.

    WHEN USING THIS PRODUCT

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

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

    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 HANDS 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), FRAGRANCE (PARFUM), CARBOMER, AMINOMETHYL PROPANOL, ISOPROPYL ALCOHOL, GLYCERIN, PROPYLENE GLYCOL, BENZOPHENONE-4, MANNITOL, CELLULOSE, TOCOPHERYL ACETATE, RETINYL PALMITATE, HYDROXYPROPYL METHYLCELLULOSE, TITANIUM DIOXIDE (CI 77891), RED 33 (CI 17200), YELLOW 5 (CI 19140), BLUE 1 (CI 42090).

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  • INGREDIENTS AND APPEARANCE
    CARE ONE  VANILLA APPLE BLOSSOM
    ethyl alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-476
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 650 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CARBOMER 934  
    AMINOMETHYLPROPANOL  
    ISOPROPYL ALCOHOL  
    GLYCERIN  
    PROPYLENE GLYCOL  
    SULISOBENZONE  
    MANNITOL  
    POWDERED CELLULOSE  
    .ALPHA.-TOCOPHEROL ACETATE  
    VITAMIN A PALMITATE  
    HYPROMELLOSES  
    TITANIUM DIOXIDE  
    D&C RED NO. 33  
    FD&C YELLOW NO. 5  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-476-02 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 02/14/2013
    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(41520-476)
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