Label: ALCOHOL FREE HAND SANITIZER 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 February 12, 2015

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  • ACTIVE INGREDIENT

    Active ingredients--------------purpose

    Ethyl Alcohol 62%------------antiseptic

  • PURPOSE

    Uses:
    Reduces bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    Warnings:

    For external use only.Flammable:Keep away from heat for flame.Do no use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • INDICATIONS & USAGE

    Directions:

    Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.

  • DOSAGE & ADMINISTRATION

    Other Information

    Do not store above 110F(43C) May discolor certain fabric or surfaces. Harmful to wood finishes and plastics.


  • KEEP OUT OF REACH OF CHILDREN

    Children under 6 years of age should be super vised when using this product.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water,Glycerin,Isopropyl Myristate, Propylene Glycol,Tocopheryl Acetate, Aminomethyl Propanol, Carbomer, Fragrance

  • PRINCIPAL DISPLAY PANEL

    image of 1oz

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE HAND SANITIZER 
    alcohol free hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 96.4501 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
    PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48) 0.5 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.2 g  in 100 g
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.2 g  in 100 g
    TOCOPHEROL (UNII: R0ZB2556P8) 0.05 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 g  in 100 g
    DMDM HYDANTOIN (UNII: BYR0546TOW) 0.15 g  in 100 g
    AROMADENDRIN (UNII: 7YA4640575) 0.03 g  in 100 g
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) 0.0075 g  in 100 g
    CYCLOHEXYL CINNAMATE (UNII: 2955WP594O) 0.009 g  in 100 g
    BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.00162 g  in 100 g
    3,7-DIMETHYL-1-OCTANOL (UNII: DPY9K1927C) 0.0018 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-230-07500 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/08/2014
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD529334491manufacture(47993-230)
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