Label: CAREONE COUNTRY APPLE- ethyl alcohol 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 17, 2017

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  • Active ingredient

    Ethyl Alcohol 65%

    Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin.
  • Warnings

    • For external use only
    • Flammable. Keep away from 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.
  • Directions

    • apply a small amount to your palm and rub hands together briskly until dry.
    • children under 6 years old should be supervised when using this product.
  • Other information

    • store at a room temperature below 110°F (43°C)
  • Inactive ingredients

    Water (Aqua), Fragrance (Parfum), Carbomer, Aminomethyl Propanol, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Glycerin, Mannitol, Cellulose, Hydroxypropyl Methylcellulose, Iron Oxides (CI 77491), Red 33 (CI 17200), Red 40 (CI 16035), Yellow 5 (CI 19140).

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    CAREONE  COUNTRY APPLE
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-410-08259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2017
    2NDC:41520-410-0359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/16/2017
    Labeler - American Sales Company (809183973)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(41520-410)
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