HAND SANITIZER by Jinhua City Wellmae Cosmetics Co., Ltd. HAND SANITIZER gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Jinhua City Wellmae Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol Denat.75% v/v

Purpose

Antiseptic

Uses

●Hand sanitizer to help reduce bacteria on the skin that could cause disease.
● For use when soap and water are not available.

WARNINGS

For external use only.
●Flammable. Keep away from heat or flame.

When using this poduct
●Keep out of eyes, ears,and mouth, ln case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a Doctor
●lf irrition or rash occurs. These may be signs of a serious condition.

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

Do not use
● ln children less than 2 months of age.
● On open skin wounds

Do not use

● ln children less than 2 months of age.
● On open skin wounds

When using this product

When using this poduct
●Keep out of eyes, ears,and mouth, ln case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a Doctor
●lf irrition or rash occurs. These may be signs of a serious condition.

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

Do not use
● ln children less than 2 months of age.
● On open skin wounds

Stop use and ask a doctor

Stop use and ask a Doctor
●lf irrition or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

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

Directions

● Place 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 to avoid swallowing.

Other Information

● Store at 68°to 77℉ (20°~25℃)
● Do not store above 110℉ (43℃)
● You may report a serious adverse reaction to Centric Beauty LLC, 3505th Avenue, New York, NY 10118

Inactive Ingredients

Water, Glycerin, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysrbate 20, Aminomethyl Propanol, Blue 1, Yellow 5, Red 28, Red 40.

Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75427-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 28 (UNII: 767IP0Y5NH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75427-016-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/16/2020

Labeler - Jinhua City Wellmae Cosmetics Co., Ltd. (543459963)

Registrant - Jinhua City Wellmae Cosmetics Co., Ltd. (543459963)

Establishment
Name	Address	ID/FEI	Business Operations
Jinhua City Wellmae Cosmetics Co., Ltd.		543459963	manufacture(75427-016)