Label: DERMOKIL- hand sanitizer 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 August 21, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the FDA OTC monograph:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (71.5%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol
    3. Isopropyl alcohol 2% (v/v)
    4. Water
    5. Sodium hydroxide 0.01% (v/v)

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 71.5% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • on children less than 2 months age
    • on open skin wounds
  • WHEN USING

    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.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Aloe barbadensis (aloe vera) leaf extract, carbomer, fragrance, glycerin, isopropyl alcohol, kaolin, sodium hydroxide, water

  • Package Label - Principal Display Panel

    Dermokil 295ml bottle pumpDermokil 295ml bottle pumpDermokil 500ml bottle pumpDermokil 3285ml 1 gallon bottle3785 mL NDC: 75801-786-37

  • INGREDIENTS AND APPEARANCE
    DERMOKIL 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75801-786
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.01 mL  in 100 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 2 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75801-786-373785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:75801-786-50500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    3NDC:75801-786-29295 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    4NDC:75801-786-23236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş. (566224588)
    Registrant - EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.S. (566224588)
    Establishment
    NameAddressID/FEIBusiness Operations
    EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş.566224588manufacture(75801-786)
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