Label: CAREONE VITAMIN E HAND SANITIZER- ethyl alcohol gel

  • 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 October 28, 2020

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  • Active Ingredients

    Ethyl Alcohol (65%)

  • Purpose

    Antiseptic

  • Uses

    For personal hand hygiene to help prevent the spread of bacterial, and can be used in place of hand washing if soap and water are not available.

  • 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. Do not inhale.

    Do not use

    • on children less than 2 months of age
    • on open skin wounds
    • on broken or damaged skin
    • if you are pregnant or breastfeeding

    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

    • For occasional and personal use
    • Rub thoroughly into hands for at least 30 seconds. Allow to 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 certain fabrics or surfaces
  • Inactive Ingredients

    Water, PEG-6, Fragrance, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer., Yellow 5 (Cl 19140), Blue 1 (Cl 42090)

  • 59 ml

    28345-1

  • 236 ml

    28345-2

  • 444 ml

    28345-3

  • 946 ml

    28345-4

  • INGREDIENTS AND APPEARANCE
    CAREONE VITAMIN E HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-200
    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)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-200-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2020
    2NDC:72476-200-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2020
    3NDC:72476-200-15444 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2020
    4NDC:72476-200-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/06/2020
    Labeler - Retail Business Services, LLC (967989935)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(72476-200)
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