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Clensil - Medication Information

Product NDC Code 75801-999
Drug Name

Clensil

Type Brand
Active Ingredients
Alcohol 71.5 ml/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 2360897
Application Number part333A
Labeler Name EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.S.
Packages
Package NDC Code Description
75801-999-37 3785 ml in 1 bottle (75801-999-37)
75801-999-50 500 ml in 1 bottle, pump (75801-999-50)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient(s) Alcohol 71.5% v/v. Purpose: Antiseptic

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Wet hands thoroughly with product allow to dry without wiping

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients glycerin, water, isopropyl alcohol, sodium hydroxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use For hand sanitizing to decrease bacteria on the skin

Purpose

Information about the drug product’s indications for use.
Purpose Antiseptic, Hand Sanitizer

Spl product data elements

Usually a list of ingredients in a drug product.
Clensil ALCOHOL ALOE VERA LEAF POLYSACCHARIDES GLYCERIN WATER ALCOHOL ALCOHOL SODIUM HYDROXIDE ISOPROPYL ALCOHOL CARBOMER 940 KAOLIN

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package Label - Principal Display Panel 3785mL BOTTLE NDC: 75801-999-37 Clensil 16 fl oz 500ml pump bottle CLENSIL 1 GALLON LABEL

Recent major changes

A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.
Use Use for hand sanitizing to decrease bacteria on the skin

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
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.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use Do not use on damaged, inflamed or broken skin

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if irritation or rash develops and lasts more than 72 hours

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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

Storage and handling

Information about safe storage and handling of the drug product.
Other information keep out of direct sunlight Store in cool, dry conditions

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Flammable. Keep away from fire or flame For external use only

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API