Label: DERMAGEL- 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 June 29, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • to decrease bacteria on the skin after changing diapers, after assisting ill persons or before contact with a person under medical care or treatment
    • recommended for repeated use.
  • WARNINGS

    Warnings

    For external use only

    Flammable. Keep away from heat or flame.

    When using this product keep away from eyes. In case of eye contact, flush with water.

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

    Keep out of reach of children. If swallowed, contact a physician or poison control center.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally to hands to cover all surfaces
    • rub hands together until dry
    • supervise children under 6 years old
    • not recommended for infants
  • INACTIVE INGREDIENT

    Ingredients Water, Glycerin, Propylene Glycol, Isopropy Myristate, Aloe Barbedensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Carbomer, Triisopropanolamine

  • SPL UNCLASSIFIED SECTION

    Manufactured for Inopak, LTD., Ringwood, NJ 07456

    1-800-762-7725 • www.inopak.com

  • PRINCIPAL DISPLAY PANEL

    DermaGel®

    HAND SANITIZING GEL with moisturizers

    70% Alcohol with ALOE VERA & VITAMIN E

    KILLS 99.99% OF GERMS!

    NET CONTENTS: 800 ML (27 FL. OZ.)

    58575-231 DermaGel 0622

  • INGREDIENTS AND APPEARANCE
    DERMAGEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-231
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    WATER (UNII: 059QF0KO0R)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58575-231-80800 mL in 1 POUCH; Type 0: Not a Combination Product06/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/29/2022
    Labeler - Inopak. Ltd (194718243)
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