Label: CAREONE LEMON- 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 April 26, 2017

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  • Active ingredient

    Ethyl Alcohol 70%

    Purpose

    Antiseptic

  • Uses

    • to help reduce 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 thoroughly with water.

    Stop use and ask a 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

    • put enough product in your palm to cover hands and rub hands together until dry.
    • children under 6 years should be supervised when using this product.
  • Other information

    • store at a temperature below 110°F (43°C)
    • may discolor some fabrics or surfaces
  • Inactive ingredients

    Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

  • Label Copy

    Image of the label

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    CAREONE  LEMON
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-941
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-941-07236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/25/2017
    2NDC:41520-941-0359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/25/2017
    Labeler - American Sales Company (809183973)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(41520-941)
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