Label: DERMESSE HAND SANITIZER GEL- hand sanitizer 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 December 22, 2021

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  • Active Ingredient:

    Ethyl Alcohol

  • Purpose

    Antimicrobial

  • USES:

    Hand sanitizer to help reduce bacteria on the skin

  • WARNINGS:

    Flammable. Keep away from fire or flame. For external use only.

  • When using the product:

    • Do not use in or near the eyes.  In case of contact, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if:

    Irritation or rash appears and lasts.

  • Keep out of reach of children.

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

  • DIRECTIONS:

    • Apply palmful to hands
    • Rub hands together vigorously until dry
    • Supervise children in the use of this product
  • Inactive Ingredients:

    Aloe Barbadensis Leaf Juice, Carbomer, Glycerin, Tocopheryl Acetate, Water

  • OTHER INFORMATION:

    • Do not store above 110oF (43oC)

    • May discolor certain fabrics or surfaces
  • Questions?:

    866-494-4466, Mon-Fri 8:00AM-5:00PM

    Dist. By Axia Medical Solutions, 2105 Camino Vida Roble, Carlsbad, Ca. 92011

  • PRINCIPAL DISPLAY PANEL

    Hand Sanitizer Label

  • INGREDIENTS AND APPEARANCE
    DERMESSE HAND SANITIZER GEL 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68723-200
    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)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68723-200-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/14/2020
    Labeler - Axia Medical Solutions, LLC (929224694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Axia Medical Solutions, LLC929224694manufacture(68723-200)
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