HAND SANITIZER ALCOHOL CLEANER- ethyl alcohol spray

Hand Sanitizer Alcohol Cleaner by

Drug Labeling and Warnings

Hand Sanitizer Alcohol Cleaner 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

Hand and surface sanitizing.

WARNINGS

■For external use only
Flammable. Keep away from fire or flame
When using this product
n Keep out of eyes. In case of contact with eyes
flush thoroughly with water
■Avoid contact with open skin
1 Do not inhale or ingest
Stop use and ask a doctor
If skin iritation or redness develops

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

Directions

Wet hands thoroughly with product and allow to dry without wiping

Children under 6 years of age use only under adult supervision.

Not recommended for infants

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER ALCOHOL CLEANER 
ethyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77753-001
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77753-001-01	12 in 1 BOX	05/20/2020
1		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 77753-001-02	12 in 1 BOX	05/20/2020
2		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 77753-001-03	12 in 1 BOX	05/20/2020
3		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 77753-001-04	12 in 1 BOX	05/20/2020
4		53 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 77753-001-05	12 in 1 BOX	05/20/2020
5		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 77753-001-06	8 in 1 BOX	05/20/2020
6		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 77753-001-07	8 in 1 BOX	05/20/2020
7		236 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 77753-001-08	8 in 1 BOX	05/20/2020
8		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 77753-001-09	4 in 1 BOX	05/20/2020
9		473 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 77753-001-10	4 in 1 BOX	05/20/2020
10		500 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	05/20/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
SHANDISHI Biological Technology Co., Ltd.		411868994	manufacture(77753-001)