Label: ER HAND SANITIZER PACKETS- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol, 75% v/v

  • PURPOSE

    Purpose  Antiseptic

  • INDICATIONS & USAGE

    Uses

    • Hand sanitizer to 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

    • In children less than 2 months of age
    • On open skin wounds
    • 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

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

  • DOSAGE & ADMINISTRATION

    Directions 

    Place enough products on hands to cover all surfaces. Rub hands together until dry

    Supervise children under 6 years of age when using this product to avoid swallowing

  • STORAGE AND HANDLING

    Other information

    Store in a cool dry area 15 to 30C (59 to 86F)

    Avoid freezing and excessive heat above 40V (104F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates/ C10-C30 alkyl acrylate crossploymer, Aminomethyl propanol, Aloe barbadensis leaf jiuce, Denatonium benzoate, Fragrance, Glycerin, Maltodextrin, Propylene glycol, Tocopheryl acetate, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ER HAND SANITIZER PACKETS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72976-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    TOCOPHERYL GLUCOSIDE (UNII: 9CKD1JE38R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALOE (UNII: V5VD430YW9)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLE (candy apple) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72976-016-01114 in 1 BOX01/11/2024
    10.9 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/14/2023
    Labeler - EVER READY FIRST AID (147372960)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(72976-016)
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