KLAREX CLEAR TM- alcohol antiseptic 62% topical solution solution KLAREX CLEANSE TM- alcohol antiseptic 80% topical solution solution

Klarex Cleanse by

Drug Labeling and Warnings

Klarex Cleanse by is a Otc medication manufactured, distributed, or labeled by HUNGARO-GAL KFT. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredients

Drug Facts

Active ingredient

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

Prupose

Antiseptic

Use

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

Warnings

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

Do not use

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

When 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

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

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

Directions

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

Other Information

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

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

Inactive Ingredients

Inactive Ingredients glycerin, hydrogen peroxide, purified water USP

Indications and Usage

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

Dosage and Administration

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

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 germs

Klarex Clear Principal Display panel

Klarex Cler

Hand Sanitizer

INGREDIENTS AND APPEARANCE

KLAREX CLEAR  TM
alcohol antiseptic 62% topical solution solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73753-622
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCETH-7 (UNII: 58Y261JLH5)
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73753-622-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2020
2	NDC: 73753-622-02	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2020
3	NDC: 73753-622-03	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2020
4	NDC: 73753-622-04	125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2020
5	NDC: 73753-622-05	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2020
6	NDC: 73753-622-06	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/03/2020

KLAREX CLEANSE  TM
alcohol antiseptic 80% topical solution solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73753-821
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	18.425 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73753-821-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
2	NDC: 73753-821-02	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
3	NDC: 73753-821-03	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
4	NDC: 73753-821-04	125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
5	NDC: 73753-821-05	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
6	NDC: 73753-821-06	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/27/2020

Labeler - Hungaro-Gal Kft (425075947)