DERMOKIL- hand sanitizer gel 
EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş.

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.

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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

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 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.

Directions

Other information

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

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)

Revised: 8/2020
Document Id: ad61a7b3-37c2-f4f9-e053-2995a90a0389
Set id: a44c3def-3be0-71d7-e053-2995a90aa149
Version: 7
Effective Time: 20200821
 
EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş.