Label: LITTLE ONES BABY FRESH SANITIZER- 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 28, 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 THOROUGHLY WITH WATER

    STOP USE AND ASK A DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS OR LASTS

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. 1-800-222-1222

  • DIRECTIONS

    • PUT ENOUGH PRODUCT IN YOU 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 CERTAIN FABRICS OR SURFACES
  • INACTIVE INGREDIENTS

    WATER (AQUA), PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, CARBOMER, AMINOMETHYL PROPANOL, BENZOPHENONE-4, GLYCERIN, FRAGRANCE (PARFUM), RED 33 (CI 17200)

  • QUESTIONS OR COMMENTS?

    1-800-842-7886

  • LABEL COPY

    IMAGE OF THE LABEL

  • LABEL COPY

    IMAGE OF THE LABEL

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    LITTLE ONES  BABY FRESH SANITIZER
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-413
    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)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-413-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:49738-413-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:49738-413-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/27/2015
    Labeler - KMART CORPORATION (008965873)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(49738-413)
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