Label: ANTIBACTERIAL HAND SANITIZER- 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 September 22, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help decrease bacteria on the skin.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame. Keep out of eyes, ears & mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask doctor if redness or irritation develop and persist 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 on childeren less than 2 months of age. Do not use on open skin wounds.

  • Do not use

  • 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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask doctor if redness or irritation develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Squeeze enough product on hands to cover all surface. Rub hands together until dry.

  • Other information

    • Store at 20℃ (68-77℉)
    • May discolor fabrics.
  • Inactive ingredients

    Water, Carbomer, 2-Amino-2-Methyl-1-Propanol, Fragrance.

  • Package Label - Principal Display Panel

    60 mL NDC: 70445-060-01

    60 ml label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70445-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70445-060-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Webb Business Promotions, Incorporated (154445647)
    Registrant - Dongyang Medical & Hygienic Articles Co., Ltd. (530310429)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongyang Medical & Hygienic Articles Co., Ltd.530310429manufacture(70445-060)
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