Label: HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 47993-329-01, 47993-329-02
  • Packager: INGBO JIANGBEI OCEAN STAR TRADING CO.,LTD
  • 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 June 17, 2021

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  • ACTIVE INGREDIENT

    Active ingredients

    Alcohol 71% v/v

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Uses：

    Hand sanitizer to help reduce germs on the skin that potentially can cause disease.

  • WARNINGS

    Warnings:

    Flammable. Keep away from fire or flame

    For external use only.

  • STOP USE

    Discontinue use and ask a doctor if

    • Irritation and redness develop.
    • Condition persists for more than 72 hours.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Spray on clean, dry hands and nails.
    • Wet hands thoroughly with product.
    • Rub hands together for no less than 15 seconds, paying particular attention to interdigital spaces, fingernails and cuticles.
    • Allow to dry without wiping.
    • Rub hands together briskly until dry.
  • OTHER SAFETY INFORMATION

    Other information:

    Store in a cool, dry place below 104℉ (40℃).

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Isopropyl Alcohol, Glycerin, Glyceryl Laurate.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-329
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-329-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/16/2021
    2NDC:47993-329-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/16/2021
    Labeler - INGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
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