DR.CLEAN- alcohol gel 
PH Holdings

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

500ml NDC: 76850-201-01 Label

DR.CLEAN 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76850-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
TROMETHAMINE (UNII: 023C2WHX2V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76850-201-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/10/2020
Labeler - PH Holdings (694838903)
Registrant - Geukdong Chemical (689755747)
Establishment
NameAddressID/FEIBusiness Operations
Geukdong Chemical689755747manufacture(76850-201)

Revised: 4/2020
Document Id: a4214a82-3142-2c37-e053-2995a90a5b85
Set id: a4214a82-3141-2c37-e053-2995a90a5b85
Version: 1
Effective Time: 20200425
 
PH Holdings