Label: HAND SANITIZER 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 July 8, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Use

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only. Flammable. Keep away from fire and flame.

    Do not use in the eyes. Incase of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours.

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

  • Do not use

    Do not use in the eyes. Incase of contact, rinse eyes thoroughly with water.

  • WHEN USING

    For external use only. Flammable. Keep away from fire and flame.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops and 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 right away.

  • Directions

    Wet hands thoroughly with product. briskly rub hands together until dry.

    Supervise children under 6 years in the use of this product.

  • Other information

    Store at 20°C to 25°C (68°to 77°F )

    May discolor certain fabrics.

  • Inactive ingredients

    Water (Aqua), Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Aloe Barbadensis Leaf Juice.

  • Package Label - Principal Display Panel

    60.

    500

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76681-002
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    CARBOMER 934 (UNII: Z135WT9208)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76681-002-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:76681-002-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Taizhou Huangyan Delishi Daily Necessity Co., Ltd. (527795950)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taizhou Huangyan Delishi Daily Necessity Co., Ltd.527795950manufacture(76681-002)
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