FDA.reportPublic FDA data

Klarex Cleanse

Manufacturer
HUNGARO-GAL KFT
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:47:12

Label at a glance#

ProductKlarex Cleanse tm
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Indicatons and Usage: Use for cleansing your hands when soap is not available

Dosage and administration

Directions * Place enough product on hands to cover all surfaces. Rub hands together until dry. * Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Drug Facts Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Drug FactsDrug FactsDrug Facts

Active ingredient

Ethyl Alcohol 80% v/v....................................

Prupose

Antiseptic

Use

OTC - PURPOSE SECTION

Use to kill germs on the skin which may cause disease - formulated for repeated useUse to kill germs on the skin which may cause disease - formulated for repeated useUse to kill germs on the skin which may cause disease - formulated for repeated use

Warnings

WARNINGS SECTION

Warnings For external use only. Flammable. Keep away from heat or flame.Warnings For external use only. Flammable. Keep away from heat or flame.Warnings For external use only. Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

Do not use * in children less than 2 month of age * on open skin woundsDo not use * in children less than 2 month of age * on open skin woundsDo not use * in children less than 2 month of age * on open skin wounds

When using this product

OTC - WHEN USING SECTION

When using this productWhen using this product

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thorouthly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep 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

INSTRUCTIONS FOR USE SECTION

Directions * Place enough product on hands to cover all surfaces. Rub hands together until dry. * Supervise children under 6 years of age when using this product to avoid swallo...Directions * Place enough product on hands to cover all surfaces. Rub hands together until dry. * Supervise children under 6 years of age when using this product to avoid swallo...Directions * Place enough product on hands to cover all surfaces. Rub hands together until dry. * Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

INFORMATION FOR PATIENTS SECTION

Other Information * Store between 15-30OC (59-86OF) * Avoid freezing and excessive heat above 40OC (104OF)Other Information * Store between 15-30OC (59-86OF) * Avoid freezing and excessive heat above 40OC (104OF)

Other Information

* Store between 15-30OC (59-86OF)

* Avoid freezing and excessive heat above 40OC (104OF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Inactive Ingredients glycerin, hydrogen peroxide, purified water USP

Indications and Usage

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

Indicatons and Usage: Use for cleansing your hands when soap is not available

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Dosage and Administration: wet hands thoroughly with product and allow to dry without wiping

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KLAREX cleanse tm Alcohol Antiseptic 80% Topical Solution Non-sterile Solution e 33.8 FL OZ (1000ml) Hand Sanitizer who-recommended Hand Sanitizer Formulation Kills 99.9% of germsKLAREX cleanse tm Alcohol Antiseptic 80% Topical Solution Non-sterile Solution e 33.8 FL OZ (1000ml) Hand Sanitizer who-recommended Hand Sanitizer Formulation Kills 99.9% of germs

KLAREX cleanse tm

Alcohol Antiseptic 80%

Topical Solution

Non-sterile Solution

e 33.8 FL OZ (1000ml)

Hand Sanitizer

who-recommended Hand Sanitizer Formulation

Kills 99.9% of germs

Klarex Clear Principal Display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

klarex clear principal display panelklarex clear principal display panel

Klarex Cler

Hand Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN6
1039339ethanol 0.8 ML/ML Topical SolutionSCD6
1039339ethanol 80 % Topical SolutionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73753-821-012023-07-28C16284748780-1c7ccaba7-1fef-fd44-e053-dadaa90aa01ba1391a2b-81b6-51eb-e053-2a95a90a2d5e
73753-821-022023-07-28C16284748780-1c7ccaba7-1fef-fd44-e053-dadaa90aa01ba1391a2b-81b6-51eb-e053-2a95a90a2d5e
73753-821-032023-07-28C16284748780-1c7ccaba7-1fef-fd44-e053-dadaa90aa01ba1391a2b-81b6-51eb-e053-2a95a90a2d5e
73753-821-042023-07-28C16284748780-1c7ccaba7-1fef-fd44-e053-dadaa90aa01ba1391a2b-81b6-51eb-e053-2a95a90a2d5e
73753-821-052023-07-28C16284748780-1c7ccaba7-1fef-fd44-e053-dadaa90aa01ba1391a2b-81b6-51eb-e053-2a95a90a2d5e
73753-821-062023-07-28C16284748780-1c7ccaba7-1fef-fd44-e053-dadaa90aa01ba1391a2b-81b6-51eb-e053-2a95a90a2d5e
73753-821-072023-07-28C16284748780-1c7ccaba7-1fef-fd44-e053-dadaa90aa01ba1391a2b-81b6-51eb-e053-2a95a90a2d5e
73753-611-052022-01-19C16284748780-1c7ccaba7-1fef-fd44-e053-dadaa90aa01ba1391a2b-81b6-51eb-e053-2a95a90a2d5e
73753-611-052021-07-23C16284748780-1c7ccaba7-1fef-fd44-e053-dadaa90aa01ba1391a2b-81b6-51eb-e053-2a95a90a2d5e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73753-821-01Klarex Cleansetm1000 mL in 1 BOTTLE, PLASTICSOLUTION10006
73753-821-02Klarex Cleansetm500 mL in 1 BOTTLE, PLASTICSOLUTION5006
73753-821-03Klarex Cleansetm300 mL in 1 BOTTLE, PLASTICSOLUTION3006
73753-821-04Klarex Cleansetm125 mL in 1 BOTTLE, PLASTICSOLUTION1256
73753-821-05Klarex Cleansetm60 mL in 1 BOTTLE, PLASTICSOLUTION606
73753-821-06Klarex Cleansetm30 mL in 1 BOTTLE, PLASTICSOLUTION306
73753-821-07Klarex Cleansetm5000 mL in 1 BOTTLE, PLASTICSOLUTION50006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73753-821KLAREX CLEANSE TM (ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION) SOLUTION [HUNGARO-GAL KFT]6Legacy NDC, 7 package rows20220120_a1391a2b-81b6-51eb-e053-2a95a90a2d5e.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73753-82173753-821-01, 73753-821-02, 73753-821-03, 73753-821-04, 73753-821-05, 73753-821-06, 73753-821-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT

Source Document#

Source XML · Source PDF

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
d5799f45-37f7-c13d-e053-2a95a90a6b6ea1391a2b-81b6-51eb-e053-2a95a90a2d5e2022-01-17WarningsExact identifier
spl id: d5799f45-37f7-c13d-e053-2a95a90a6b6e
spl set id: a1391a2b-81b6-51eb-e053-2a95a90a2d5e

Reported adverse events (FAERS/openFDA)#

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