Label: CAREONE ANTIBACTERIAL SANITIZER FRESH WATER- 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 March 4, 2015

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 65%

    PURPOSE

    ANTISEPTIC

  • USES

    TO HELP 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 THOROUGHLY WITH WATER

    STOP USING 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 HAND TOGETHER UNTIL DRY
    • CHIDREN 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 (AQUA), PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, CARBOMER, AMINOMETHYL PROPANOL, GLYCERIN, FRAGRANCE (PARFUM), BENZOPHENONE-4, POLYETHYLENE, ULTRAMARINES (CI 77007), BLUE 1 (CI 42090), RED 33 (CI 17200)

  • LABEL COPY

    IMAGE OF THE LABEL

  • LABEL COPY

    IMAGE OF THE LABEL2

  • INGREDIENTS AND APPEARANCE
    CAREONE  ANTIBACTERIAL SANITIZER FRESH WATER
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-412
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CARBOMER 934 (UNII: Z135WT9208)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-412-0259 mL in 1 BOTTLE, PLASTIC
    2NDC:41520-412-09259 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/03/2015
    Labeler - AMERICAN SALES COMPANY (809183973)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41520-412)
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