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(s)

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For External Use Only. Flammable. Keep Away From Heat Or Flame.

Do not use

●ON CHILDREN LESS THAN 2 MONTHS OF AGE

●ON OPEN SKIN WOUNDS

WHEN USING

keep out of ears, eyes and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

if iritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

Directions

●Place enough product on hands to cover all surfaces. Rub hands together until dry.

●Supervise children under 6 years of age when using this product to avoid swallowing

Other information

●Store between 59°-86°F (15°-30℃)

●Do not store above 104°F (40℃)

Inactive ingredients

●Water (Aqua), Propylene Glycol, Glycerine, Carbopol 940, Triethanolamine

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75427-001
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
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75427-001-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Jinhua City Wellmae Cosmetics Co., Ltd.		543459963	manufacture(75427-001)