DR TOC PERFECT CLEAN GEL- alcohol liquid
C3 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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C3 Co., Ltd. - isLeaf Hand Cleaning Gel

Alcohol

Water, Glycerin, Carbomer, Polyacrylate Crosspolymer-6, Octyldodeceth-16, Ammonium Acryloyldimethyltaurate/VP Copolymer, Tromethamine, Butylene Glycol, Portulaca Oleracea Extract, 1,2-Hexanediol

Antiseptic

keep out of reach of the children

Open the pouch, apply an appropriate amount to your hands, then rub well to dry.

For external use only.

Avoid contact with eyes.

Keep out of reach of children.

Discontinue use if skin irritation occurs.

for external use only

label

DR TOC PERFECT CLEAN GEL
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70818-028
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	74 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70818-028-01	2 mL in 1 POUCH; Type 0: Not a Combination Product	02/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/14/2021

Labeler - C3 Co., Ltd. (689846633)

Registrant - C3 Co., Ltd. (689846633)

Name	Address	ID/FEI	Business Operations
Establishment
C3 Co., Ltd.		689846633	pack(70818-028) , manufacture(70818-028) , label(70818-028)

Revised: 2/2021

Document Id: bb4769eb-e8e9-7fe7-e053-2995a90a4231

Set id: bb4766b7-5e4d-b527-e053-2a95a90a1aa3

Version: 1

Effective Time: 20210214

C3 Co., Ltd.