DISINFEX- alcohol gel 
RK KOZMETIK VE HIJYEN URUNLERI SANAYI DIS 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) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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 (0.5% v/v).
  3. Aloe Vera Leaf (0.1% v/v).
  4. Carbomer 940 (0.3% v/v).
  5. Aminomethylpropanol (0.15% v/v).
  6. Sterile distilled 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, Disinfex Hand Sanitizer

Uses

to help reduce bacteria on the skin. For use when soap and water are not avaliable.

Warnings

For external use only. Flammable liquid and vapor. Keep away from heat/sparks/open flame. No smoking. Avoid sprayin in eyes.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness devolops and lasts.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a poison Control Center immediately.

Directions

Other information

Inactive ingredients

Water (Aqua), Glycerin, Aloe Barbadensis Leaf Juice, Carbomer, Aminomethylpropanol.

Package Label - Principal Display Panel

250 mL NDC: 79320-120-03 250 ML LABEL

DISINFEX 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79320-120
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
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.15 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79320-120-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/2020
Labeler - RK KOZMETIK VE HIJYEN URUNLERI SANAYI DIS TICARET ANONIM SIRKETI (520068126)

Revised: 7/2020
Document Id: aacee63a-de03-13e4-e053-2a95a90a5a1d
Set id: aacee63a-de04-13e4-e053-2a95a90a5a1d
Version: 1
Effective Time: 20200719
 
RK KOZMETIK VE HIJYEN URUNLERI SANAYI DIS TICARET ANONIM SIRKETI