Label: PREMIUM HAND SANITIZER GEL- alcohol gel

  • NDC Code(s): 81524-111-01, 81524-111-04, 81524-111-07
  • Packager: SOOTSOAP SUPPLY CO LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 26, 2024

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  • Directions

    - Place enough product 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.

  • Inactive Ingredients

    Purified water, Aloe Barbadensis Leaf Juice Powder, Hydroxyethyl cellulose, Mentha Piperita (Peppermint) Essential Oil

  • Uses

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

    For use when soap and water are not available.

  • Keep out of reach of children.

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

  • Purpose

    Antiseptic

  • Active Ingredient[s]

    Alcohol (Ethanol) 70% v/v

  • Warnings

    - For external use only. Flammable. Keep away from heat or flame.

    - Do not use in children less than 2 months of age. Do not use in open skin wounds.

    - 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.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    PREMIUM HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81524-111
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Product Characteristics
    Colorgray (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81524-111-015 mL in 1 BOTTLE; Type 0: Not a Combination Product02/12/2021
    2NDC:81524-111-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product02/12/2021
    3NDC:81524-111-07473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/12/2021
    Labeler - SOOTSOAP SUPPLY CO LTD (204255801)
    Registrant - SOOTSOAP SUPPLY CO LTD (204255801)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(81524-111)
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