Clensil by EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş. CLENSIL- alcohol gel

Clensil by

Drug Labeling and Warnings

Clensil by is a Otc medication manufactured, distributed, or labeled by EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the OTC Monograph published in April 2019.

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)

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. Glycerine (inactive)
3. Water (inactive)
4. Isopropyl alcohol (2% volume/volume (v/v)) (inactive)
5. Sodium hydroxide (0.01% (v/v)) (inactive)

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

For hand sanitizing to decrease bacteria on the skin

Warnings

Flammable. Keep away from fire or flame

For external use only

Do not use

Do not use on damaged, inflamed or broken skin

WHEN USING

Avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or rash develops and lasts for more than 72 hrs

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 develops and lasts more than 72 hours

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

• Wet hands thoroughly with product
• allow to dry without wiping

Other information

• keep out of direct sunlight
• Store in cool, dry conditions

Inactive ingredients

glycerin, water, isopropyl alcohol, sodium hydroxide

Package Label - Principal Display Panel

3785mL BOTTLE NDC: 75801-999-37

INGREDIENTS AND APPEARANCE

CLENSIL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75801-999
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	71.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.01 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	2 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)
KAOLIN (UNII: 24H4NWX5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75801-999-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2020
2	NDC: 75801-999-37	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020

Labeler - EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş. (566224588)

Registrant - EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş. (566224588)

Establishment
Name	Address	ID/FEI	Business Operations
EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş.		566224588	manufacture(75801-999)