DR.BETTER HOMES HAND CLEAN- alcohol gel 
UI COSMETICS CO., LTD

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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75615-0010

Alcohol

Water, Glycerin, Carbomer, Triethanolamine, Fragrance

Antiseptic

KEEP OUT OF REACH OF THE CHILDREN

For the external use only

Do not use on the following body parts.
Around the eyes and ears, in the oral cavity, a wide range of body parts and damaged skin (may have irritating effects)
If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.

Symptoms of skin irritation

Other precautions

For external use only
Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
Be careful not to inhale vapor when using it extensively or for a long time. (If you drink ethanol vapor in large quantities or repeatedly, irritation to the mucous membrane, headache, etc. may occur).
When repeated use on the same site, be careful as the skin may become rough due to degreasing.
When used in sealed bandages, cast bandages, packs, etc., irritation symptoms may appear.
Do not use for any other purpose.

Put a suitable amount on your hand and rub it well to dry

1

DR.BETTER HOMES HAND CLEAN 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75615-0010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75615-0010-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2020
Labeler - UI COSMETICS CO., LTD (688362189)
Registrant - UI COSMETICS CO., LTD (688362189)
Establishment
NameAddressID/FEIBusiness Operations
UI COSMETICS CO., LTD688362189label(75615-0010) , manufacture(75615-0010)

Revised: 1/2021
Document Id: b93d989b-4db7-8e40-e053-2a95a90a5550
Set id: a3db571a-1def-ae77-e053-2995a90a981d
Version: 6
Effective Time: 20210119
 
UI COSMETICS CO., LTD