HAND SANITIZER- ethyl alcohol spray

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]

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin.

WARNINGS

Flammable, Keep away fromn fire or flame.
For external use only
When using this product avoid contact with eyes. If
contact occurs rinse eyes thoroughly with water.
Stop use and ask a doctor if skin iritation or rash develops
and continues for more than 72 hours.

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

Directions

●Place enough product in your palm to thoroughly cover
your hands.●Children under 6 years of age should be
supervised when using this product.●Rub hands together
briskly until dry.●Not recommended for infants.

Inactive ingredients

Aloe vera leaf juice, Glycerin, Fragrance(parfum) ,Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77753-003
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)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77753-003-01	12 in 1 BOX	05/29/2020
1		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 77753-003-02	12 in 1 BOX	05/29/2020
2		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 77753-003-03	12 in 1 BOX	05/29/2020
3		20 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 77753-003-04	2 in 1 BOX	05/29/2020
4		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 77753-003-05	12 in 1 BOX	05/29/2020
5		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 77753-003-06	8 in 1 BOX	05/29/2020
6		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 77753-003-07	8 in 1 BOX	05/29/2020
7		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 77753-003-08	8 in 1 BOX	05/29/2020
8		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 77753-003-09	4 in 1 BOX	05/29/2020
9		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 77753-003-10	4 in 1 BOX	05/29/2020
10		1000 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	05/29/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
SHANDISHI Biological Technology Co., Ltd.		411868994	manufacture(77753-003)