Dr.Clean by PH Holdings / Geukdong Chemical DR.CLEAN- alcohol gel

Dr.Clean by

Drug Labeling and Warnings

Dr.Clean by is a Otc medication manufactured, distributed, or labeled by PH Holdings, Geukdong Chemical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient[s]

Ethanol 72%

Purpose

Antiseptic

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

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

Do not use

- in children less than 2 months of age

- on open skin wounds

When using this product

keep out of eyes, ears, and mouth.

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.

If swallowed, get medical help or contact a Poison Control Center right away.

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

- Store between 15-30C (59-86F)

- Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredient[s]

Purified Water, Acrylate/C10-30 Alkyl Acrylate Cross Polymer, Glycerin, Tromethamine

Precautions for Use

1. If you have any of the following abnormalities using the product,

you must stop using it and as it worsens, please consult a dermatologist, etc.

(While you are using, there are abnormalities such as red spots, swelling,

itching, irritation, etc. and the applied area has the above-mentioned

abnormalities due to direct sunlight)

2. Do not use on areas with wounds or areas with eczema and dermatitis.

3. If it gets into your eyes, wash them immediately with water.

4. Precautions for storage and handling

▷ After use, be sure to close the cap.

▷ Keep out of reach of children.

▷ Do not store in a place with high or low temperature and direct sunlight.

5. This product is not a food / beverage, so do not use it for any purpose

other than its original purpose. If you ingest it, be sure to consult a doctor.

6. Be careful not to get on clothes.

7. Please note that there is a risk of slipping when in contact with the product contents.

Package Label

INGREDIENTS AND APPEARANCE

DR.CLEAN 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76850-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROMETHAMINE (UNII: 023C2WHX2V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76850-201-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/10/2020

Labeler - PH Holdings (694838903)

Registrant - Geukdong Chemical (689755747)

Establishment
Name	Address	ID/FEI	Business Operations
Geukdong Chemical		689755747	manufacture(76850-201)