HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Wenzhou Shengkai Technology Industry Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethy Alcohol 75%

Purpose

Antiseptic

Use

Use:Help reduce bacteria that potentially can cause disease.

WARNINGS

For externaluse on/y. Flammable. Keep away from heat o1 flame.
Do not use
In children less than 2 months of age On open skin wounds.
Allergic to alcohol
When using this product
Keep out ofeyes, ears, and mouth./n case of contact with eyes,
rinse eyes thoroughly with water.
Stop use: stop use and ask a doctor if irritation or rash occurs

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

Directions

Take out the product and spread it on your skin until dry.
Supervise children under 6 years of age when using this product to
avoid swallowing.

Inactive ingredients

Water, Carbomer

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78019-800
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
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78019-800-01	2 mL in 1 BAG; Type 0: Not a Combination Product	06/29/2020
2	NDC: 78019-800-02	3 mL in 1 BAG; Type 0: Not a Combination Product	06/29/2020
3	NDC: 78019-800-03	5 mL in 1 BAG; Type 0: Not a Combination Product	06/29/2020
4	NDC: 78019-800-04	10 mL in 1 BAG; Type 0: Not a Combination Product	06/29/2020
5	NDC: 78019-800-05	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
6	NDC: 78019-800-06	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
7	NDC: 78019-800-07	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
8	NDC: 78019-800-08	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
9	NDC: 78019-800-09	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
10	NDC: 78019-800-10	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
11	NDC: 78019-800-11	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/29/2020

Labeler - Wenzhou Shengkai Technology Industry Co., Ltd. (548518819)

Establishment
Name	Address	ID/FEI	Business Operations
Wenzhou Shengkai Technology Industry Co., Ltd.		548518819	manufacture(78019-800)