HAND SANITIZER- alcohol gel

Hand sanitizer by

Drug Labeling and Warnings

Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Dongguang Shuoguo Silicone Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Alcohol 62%

Purpose

Antiseptic

Use

Use for hand-washing to decrease bacteria on
the skin, only when water is not available

Warnings

For etemal use only
Flammabl, keep away from fife and fames
When using this poduct
■do not get intoeyes.
iicnacocur, inine eyes hrougwth water
Stop use and aska doctorif
iritation and redness develop

Keep out of reach of children

Keep out of reach of cilden. if sallowed, get
medical help or contact a Poison ControlCenter
right away

Directions

■wethands trougly with poduotd and alw
todry wthout wiping

INACTIVE INGREDIENT

Water, PEG-40
Hydrogenated Castor 0il, Fragrance,
AcylatesC10-30 Alkyl Acrylate Crospolymer,
Sodium Hydroxide, Denatonium Benzoate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70939-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG-40 STEARATE (UNII: ECU18C66Q7)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70939-003-02	300 in 1 BOX	05/07/2020
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 70939-003-01	48 in 1 BOX	05/07/2020
2		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 70939-003-03	200 in 1 BOX	05/07/2020
3		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 70939-003-04	200 in 1 BOX	05/07/2020
4		40 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 70939-003-05	200 in 1 BOX	05/07/2020
5		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 70939-003-06	200 in 1 BOX	05/07/2020
6		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 70939-003-07	150 in 1 BOX	05/07/2020
7		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 70939-003-08	150 in 1 BOX	05/07/2020
8		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 70939-003-09	24 in 1 BOX	05/07/2020
9		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 70939-003-10	12 in 1 BOX	05/07/2020
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	05/06/2020

Labeler - Dongguang Shuoguo Silicone Products Co., Ltd. (544426629)

Establishment
Name	Address	ID/FEI	Business Operations
Dongguang Shuoguo Silicone Products Co., Ltd.		544426629	manufacture(70939-003)