Label: 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 November 5, 2020

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  • ACTIVE INGREDIENT

    Active ingredients

    Ethyl Alcohol 62.5%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Uses：

    Hand sanitizer can help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • WARNINGS

    Warnings:

    For external use only. Flammable. Keep away from heat or flame.

  • DO NOT USE

    Do not use：

    • In children less than 2 months of age.
    • On open skin wounds.
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Surpervise children under 6 years of age when using this product to avoid swallowing.
  • OTHER SAFETY INFORMATION

    Other info:

    • Store between 15-30℃（59-86℉）
    • Avoid freezing and excessive heat above 40℃（104℉）
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water (Aqua), Glycerin, Fragrance / Parfum, Carbomer, Aminomethyl propanol, Propanediol, Simmondsia chinensis (jojoba) seed oil, Aloe barbadensis (aloe vera) leaf juice, Propylene glycol, Tocopheryl acetate, Helianthus annuus (sunflower) seed oil, Actinidia chinesis (kiwi) fruit extract, Fragaria chiloensis ( strawberry) fruit extract, Punica granatum (pomegranate) fruit extract, Vaccinium angustifolium (blueberry) fruit extract, Vaccinium macrocarpon (cranberry) fruit extract.

  • PRINCIPAL DISPLAY PANEL

    image of hand sanitizer 473ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-285
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 g  in 112 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    FRAGARIA VESCA LEAF (UNII: I14FE7JUBB)  
    PUNICA GRANATUM LEAF (UNII: O9486I5JXI)  
    VACCINIUM ANGUSTIFOLIUM LEAF (UNII: B4L873GNG1)  
    CRANBERRY JUICE (UNII: Y74M3X3345)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-285-01473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/23/2020
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
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