WASH-FREE HAND SANITIZER gel

Wash-free hand sanitizer by

Drug Labeling and Warnings

Wash-free hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhongshan Dermey Commodity Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help decrease bacteria on the surface of skin.

Warnings

Flammable, Keep away from source of heat,fire or flame.
For external use only.
Do not apply around the eyes.
Do not use in ears & mouth.

Do not use

Do not apply around the eyes.
Do not use in ears & mouth.

WHEN USING

When using this product
Avoid contact with eyes.
If contact occurs, rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if
Irritation or redness develops and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children
Children must be supervised in use of this product.

Directions

Pump enough product into your plams and thoroughly spread on both hands, rub into skin until dry. Children under 6 years should be supervised when using this product.

Other information

Store at temperature below 43°C (110°F)

Inactive ingredients

Water, triethanolamine, glycerin, carbomer

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

WASH-FREE HAND SANITIZER 
wash-free hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55028-015
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
GLYCERIN (UNII: PDC6A3C0OX)
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: 55028-015-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 55028-015-02	500 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 Drug	M016	03/30/2020

Labeler - Zhongshan Dermey Commodity Co., Ltd. (550280464)

Establishment
Name	Address	ID/FEI	Business Operations
Zhongshan Dermey Commodity Co., Ltd.		550280464	manufacture(55028-015)