DISINFEX by RK KOZMETIK VE HIJYEN URUNLERI SANAYI DIS TICARET ANONIM SIRKETI DISINFEX- alcohol gel

DISINFEX by

Drug Labeling and Warnings

DISINFEX by is a Otc medication manufactured, distributed, or labeled by RK KOZMETIK VE HIJYEN URUNLERI SANAYI DIS TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Put enough product in your palm to cover hands and rub hands together until dry.
• Children under 6 years should be supervised when using this product.

Other information

• Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F)
• may discolor certain fabrics or surfaces.

Inactive ingredients

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

Package Label - Principal Display Panel

250 mL NDC: 79320-120-03

INGREDIENTS AND APPEARANCE

DISINFEX 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79320-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79320-120-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2020

Labeler - RK KOZMETIK VE HIJYEN URUNLERI SANAYI DIS TICARET ANONIM SIRKETI (520068126)