PUREASE STERILIZE ANTISEPTIC HAND SANITIZER GEL- alcohol gel

PUREASE STERILIZE ANTISEPTIC HAND SANITIZER Gel by

Drug Labeling and Warnings

PUREASE STERILIZE ANTISEPTIC HAND SANITIZER Gel by is a Otc medication manufactured, distributed, or labeled by Beauty Plus Trading Co., Inc, Devolver Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

in the eyes

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands thoroughly with product and allow to dry without wiping

Other information

Store below 106F (41C)

May discolor certain fabrics or surfaces

Inactive ingredients

Purified Water, Glycerin, Carbomers, Mentha Herb Oil, Trolamine, Aleo Extract(09), Parsley Extract

Package Label

INGREDIENTS AND APPEARANCE

PUREASE STERILIZE ANTISEPTIC HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78399-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHA ARVENSIS TOP (UNII: 8J5Y2F7A5X)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PARSLEY (UNII: 58FMD0Q0EV)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78399-201-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/26/2020

Labeler - Beauty Plus Trading Co., Inc (793114448)

Registrant - Devolver Cosmetics Co., Ltd (695733244)

Establishment
Name	Address	ID/FEI	Business Operations
Devolver Cosmetics Co., Ltd		695733244	manufacture(78399-201)