Label: D-GERM- alcohol gel

  • NDC Code(s): 65585-498-01, 65585-498-02
  • Packager: Whisk Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • Active Ingredient

    Ethyl Alcohol 60% v/v

  • Purpose

    Skin Sanitizer

  • Use

    To help reduce amount of bacteria on the skin

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only. If swallowed, seek medical attention.

    When using this product do not use around or near the eyes. If contact occurs, flush eyes with water and contact doctor immediately.

    Stop use and consult a doctor when skin irritation appears and lasts.

    Keep out of reach of children.

  • Directions

    • Place a small amount of product in one hand.
    • Spread on hands and rub into skin until dry.
    • Place a smaller amount of product in one hand and spread over both hands and wrists,
    • Rub into skin until dry.
    • Children should be supervised while using this product.
  • Inactive Ingredients

    Water, Glycerin, Fragrance, Carbomer, Propylene Glycol, Diisopropylamine

  • PRINCIPAL DISPLAY PANEL

    Front Label - 4 fl. oz.Back Label - 4 fl. oz.

  • INGREDIENTS AND APPEARANCE
    D-GERM 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-498
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL600 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Colorwhite (water white - colorless, crystal clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65585-498-010.118 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2023
    2NDC:65585-498-020.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/13/2023
    Labeler - Whisk Products, Inc. (834270639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whisk Products, Inc.834270639pack(65585-498) , label(65585-498)
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