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

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients

    Ethyl Alcohol 70%

  • 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:

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

  • PRINCIPAL DISPLAY PANEL

    image of hand sanitizer 1000ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-296
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 112 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CRANBERRY JUICE (UNII: Y74M3X3345)  
    PUNICA GRANATUM LEAF (UNII: O9486I5JXI)  
    VACCINIUM ANGUSTIFOLIUM LEAF (UNII: B4L873GNG1)  
    FRAGARIA VESCA LEAF (UNII: I14FE7JUBB)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-296-011000 mL in 1 BAG; Type 0: Not a Combination Product07/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/10/2020
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!