FRESH WATER HAND SANITIZER- alcohol gel 
THESKINFACTORY 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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Drug Facts

Ethyl Alcohol 62% w/w

Water, Butylene Glycol, Glycerin, Carbomer, Triethanolamine, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Artemisia Princeps Extract

Antiseptic

KEEP OUT OF REACH OF THE CHILDREN

Put enough product in your palm to thoroughly cover your hands.

Rub hands together briskly until dry.

Children under 6 years of age should be supervised when using this product.

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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

For external use only

11

FRESH WATER HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74773-0015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74773-0015-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/2020
Labeler - THESKINFACTORY Co., Ltd. (694804099)
Registrant - THESKINFACTORY Co., Ltd. (694804099)
Establishment
NameAddressID/FEIBusiness Operations
WHAIN COSMETIC557837595manufacture(74773-0015)
Establishment
NameAddressID/FEIBusiness Operations
THESKINFACTORY Co., Ltd.694804099label(74773-0015)

Revised: 8/2020
Document Id: ad31e103-e22d-312f-e053-2995a90a60ce
Set id: ad31c0f5-664b-8d98-e053-2995a90a9f7b
Version: 1
Effective Time: 20200818
 
THESKINFACTORY Co., Ltd.