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%(V/V)

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Uses：

    Hand sanitizer to decrease bacteria on the skin.

  • WARNINGS

    Warnings：

    For external use only-hands

    Flammable.

    Keep away from heat or flame.

  • WHEN USING

    When using this product

    • avoid contact with eyes. In case of contact flush eyes thoroughly with water.
  • STOP USE

    Stop and ask doctor if

    skin irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Wet hands thoroughly with product and allow to dry without wiping.
    • Children under 6 years of age should be supervised when using this product.
  • OTHER SAFETY INFORMATION

    Other information:

    • Do not store above 104℉ (40℃).
    • May discolor certain fabrics or surfaces.
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water (Aqua),Glycerin,Aloe Barbadensis Leaf Juice,Carbomer,Triethanolamine,Fragrance

  • PRINCIPAL DISPLAY PANEL

    image of hand sanitizer 30ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-289
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-289-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/06/2020
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
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