HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

For Hand Sanitizing

Warnings

Warnings: For external use only-hands.
Flammable: Keep away from heat and flame.
When using this product Keep out of eyes. In case of
contact with eyes, flush thoroughly with water.●Avoid contact with
broken skin.●Do not inhale or ingest.
Stop use and ask a doctor
if skin irritation develops.

Keep out of reach of children.

Keep out of reach of children

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

Directions

Wet hands thoroughly with product and allow to
dry without wiping●For children under 6 use only under adult
Supervision.●Not recommended for infants.

Other information

1 Do not store above 105°F
1 May discolor some fabrics

Inactive ingredients

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl
Acetate, Triethanolamine, Water.

Package Labeling

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77753-004
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
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77753-004-01	12 in 1 BOX	05/20/2020
1		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 77753-004-02	12 in 1 BOX	05/09/2020
2		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 77753-004-03	12 in 1 BOX	05/20/2020
3		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 77753-004-04	12 in 1 BOX	05/09/2020
4		53 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 77753-004-05	12 in 1 BAG	05/20/2020
5		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 77753-004-06	8 in 1 BOX	05/20/2020
6		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 77753-004-07	8 in 1 BOX	05/09/2020
7		236 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 77753-004-08	8 in 1 BOX	05/20/2020
8		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 77753-004-09	4 in 1 BOX	05/20/2020
9		473 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 77753-004-10	4 in 1 BOX	05/20/2020
10		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 77753-004-11	12 in 1 BOX	05/20/2020
11		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 77753-004-12	4 in 1 BOX	05/20/2020
12		1000 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 77753-004-13	4 in 1 BOX	05/20/2020
13		2000 mL in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 77753-004-14	4 in 1 BOX	05/20/2020
14		3780 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/08/2020

Labeler - SHANDISHI Biological Technology Co., Ltd. (411868994)

Establishment
Name	Address	ID/FEI	Business Operations
SHANDISHI Biological Technology Co., Ltd.		411868994	manufacture(77753-004)