Label: DERMESSENTIALS ADVANCED HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 5, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only: hands

    • Flammable, keep away from fire or flame.

    When Using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin
    • do not inhale or ingest

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hrs

    Keep out of reach of children

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

    • wet hands thoroughly with product and allow to dry without wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Other Information

    • do not store above 105 F
    • may discolor some fabrics
    • harmful to wood finishes and plastic
  • Inactive Ingredients

    Purified Water, Aloe Vera, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Triethanolamine, Vitamin E, EDTA

  • Questions? Comments?

    813-925-8454

  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    DermEssentials™

    Advanced
    GEL
    Hand Sanitizer

    KILLS 99.99% OF MOST ILLNESS
    CAUSING GERMS

    • 70% Ethyl Alcohol
    • With Vitamin E and Aloe
    • Leaves hands soft
    • Fast and Effective

    8 FL OZ (236 mL)

    Principal Display Panel - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    DERMESSENTIALS ADVANCED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64479-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64479-501-01236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/10/2020
    Labeler - SmartScience Laboratories, Inc. (035907919)
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