FDA.reportPublic FDA data

Clensil

Manufacturer
EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş.
Effective date
2023-06-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:56:02

Label at a glance#

ProductClensil
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Wet hands thoroughly with product allow to dry without wiping

Storage and handling

keep out of direct sunlight Store in cool, dry conditions

Label contents#

Full prescribing information#

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)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 71.5% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged, inflamed or broken skin

OTC - WHEN USING SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, water, isopropyl alcohol, sodium hydroxide

Use

RECENT MAJOR CHANGES SECTION

Use for hand sanitizing to decrease bacteria on the skin

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clensil 16 fl oz 500ml pump bottleClensil 16 fl oz 500ml pump bottleCLENSIL 1 GALLON LABELCLENSIL 1 GALLON LABEL3785mL BOTTLE NDC: 75801-999-37

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2360897ethanol 71.5 % Topical GelPSN3
2360897ethanol 0.715 ML/ML Topical GelSCD3
2360897ethanol 71.5 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75801-999-372024-07-30C16284748780-1c7ccaba7-1fe9-fd44-e053-dadaa90aa01bab947ab0-a585-28f4-e053-2a95a90a160f
75801-999-502024-07-30C16284748780-1c7ccaba7-1fe9-fd44-e053-dadaa90aa01bab947ab0-a585-28f4-e053-2a95a90a160f
75801-999-372024-01-30C16284748780-1c7ccaba7-1fe9-fd44-e053-dadaa90aa01bab947ab0-a585-28f4-e053-2a95a90a160f
75801-999-502024-01-30C16284748780-1c7ccaba7-1fe9-fd44-e053-dadaa90aa01bab947ab0-a585-28f4-e053-2a95a90a160f
75801-999-372023-09-01C16284748780-1c7ccaba7-1fe9-fd44-e053-dadaa90aa01bab947ab0-a585-28f4-e053-2a95a90a160f
75801-999-502023-09-01C16284748780-1c7ccaba7-1fe9-fd44-e053-dadaa90aa01bab947ab0-a585-28f4-e053-2a95a90a160f
75801-999-372021-07-23C16284748780-1c7ccaba7-1fe9-fd44-e053-dadaa90aa01bab947ab0-a585-28f4-e053-2a95a90a160f
75801-999-502021-07-23C16284748780-1c7ccaba7-1fe9-fd44-e053-dadaa90aa01bab947ab0-a585-28f4-e053-2a95a90a160f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75801-999-37Clensil3785 mL in 1 BOTTLEGEL37853
75801-999-50Clensil500 mL in 1 BOTTLE, PUMPGEL5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75801-999CLENSIL (ALCOHOL) GEL [EZEL KOZMETIK ITH. VE IHR. TIC. VE SAN. A.Ş.]3Legacy NDC, 2 package rows20230902_ab947ab0-a585-28f4-e053-2a95a90a160f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75801-99975801-999-50, 75801-999-37

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAF POLYSACCHARIDESW21O437517IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
SODIUM HYDROXIDE55X04QC32IIACT
ISOPROPYL ALCOHOLND2M416302IACT
CARBOMER 9404Q93RCW27EIACT
KAOLIN24H4NWX5COIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fe602eee-2357-5b8d-e053-6394a90a719bab947ab0-a585-28f4-e053-2a95a90a160f2023-06-17WarningsExact identifier
spl id: fe602eee-2357-5b8d-e053-6394a90a719b
spl set id: ab947ab0-a585-28f4-e053-2a95a90a160f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.