FDA Label for Clensil
View Indications, Usage & Precautions
Clensil Product Label
The following document was submitted to the FDA by the labeler of this product Ezel Kozmetik Ith. Ve Ihr. Tic. Ve San. A.s.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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)
- 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.
- Glycerine (inactive)
- Water (inactive)
- Isopropyl alcohol (2% volume/volume (v/v)) (inactive)
- 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
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
Otc - 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
Otc - Stop Use
Stop use and ask a doctor if irritation or rash develops and lasts more than 72 hours
Otc - 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
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