DR.HOMES HAND CLEAN- ethanol 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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Active Ingredient

Ethanol 70%

Purpose

Antiseptic

Uses

■To help reduce bacteria on the skin

Warnings

For external use only.

Flammable, keep away from heat or flames.

When using this product

keep away from eyes. In case of eye contact,

rinse eyes with water.

Stop use and ask doctor if

irritation and redness develop and persist.

Keep out of reach of children.

Keep out of reach of children.

Directions

■ Apply a small amount in your palm and rub hands together briskly until dry.

■ Supervise children under 6 years in the use of product.

Other Information

■ Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Carbomer, Triethanolamine, Glycerin, Fragrance

Questions or Comments?

Call 82-2-3470-8367

Package Label

75615-0040-1 50ml

75615-0040-2 60ml

75615-0040-3 100ml

75615-0040-4 200ml

75615-0040-5 250ml

75615-0040-6 300ml

75615-0040-7 500ml

75615-0040-8 5000ml

DR.HOMES HAND CLEAN 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75615-0040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75615-0040-150 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2021
2NDC:75615-0040-260 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2021
3NDC:75615-0040-3100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2021
4NDC:75615-0040-4200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/19/2021
5NDC:75615-0040-5250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/19/2021
6NDC:75615-0040-6300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/19/2021
7NDC:75615-0040-7500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/19/2021
8NDC:75615-0040-85000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/19/2021
Labeler - UI COSMETICS CO., LTD (688362189)
Registrant - UI COSMETICS CO., LTD (688362189)
Establishment
NameAddressID/FEIBusiness Operations
UI COSMETICS CO., LTD688362189manufacture(75615-0040)

Revised: 1/2021
Document Id: b93957e6-658b-5c16-e053-2995a90a3d96
Set id: b93957e6-658a-5c16-e053-2995a90a3d96
Version: 1
Effective Time: 20210118
 
UI COSMETICS CO., LTD