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 May 23, 2017

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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 and 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

  • Directons

    • 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 certain fabrics or surfaces
  • Inactive ingredients

    Water (Aqua), Fragrance (Parfum), Carbomer, Aminomethyl Propanol, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Glycerin, Red 33 (CI 17200).

  • Questions or comments?

    1-800-842-7886

  • 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)  
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-413-0359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2017
    2NDC:49738-413-07236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2017
    3NDC:49738-413-33946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/22/2017
    Labeler - Kmart Corporation (008965873)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(49738-413)
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