DEX HAND SANITIZER- alcohol gel 
TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI

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 Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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 (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

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 70% 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

  • in children less than 2 months of age
  • on open skin wounds

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

  • 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

Aqua, Glycerin, Carbomer, Triethanolamine, Aloebarbadensis Extract, Tocopheryl Acetate.

Package Label - Principal Display Panel

sanitizer250 mL NDC: 76964-100-10

DEX HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76964-102
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
TROLAMINE (UNII: 9O3K93S3TK) 0.15 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 0.01 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 g  in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E) 0.25 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76964-102-12250 mL in 1 BOTTLE; 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 - TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI (535142780)
Registrant - TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI (535142780)
Establishment
NameAddressID/FEIBusiness Operations
TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI535142780manufacture(76964-102)

Revised: 5/2020
 
TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI