PURE HAND CLEAN GEL- alcohol gel

PURE HAND CLEAN Gel by

Drug Labeling and Warnings

PURE HAND CLEAN Gel by is a Otc medication manufactured, distributed, or labeled by Ester Co., Ltd., Ester Co., Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURE HAND CLEAN GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74004-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.6 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74004-132-20	20 in 1 BOX	04/16/2020
1		30 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/16/2020

Labeler - Ester Co., Ltd. (688425766)

Establishment
Name	Address	ID/FEI	Business Operations
Ester Co., Ltd.		688425766	manufacture(74004-132)