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 65%

Purpose

Antiseptic

Use

Use for hand-washing to decrease bacteria on
the skin

Warnings

For etemal use only
Flammabl, keep away from fife and fames
Do not use in the eyes
Stop use and ask a doctor if
1 riation and rednes develop
1 cndition perists for more than72
hours

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

Wateglyeri, btaine, thanolaminte,nn
ayltasC10-00 ayacylata crspoly
mer, honey, lemon peel ol, limnmene ciral.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70939-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BETAINE (UNII: 3SCV180C9W)
GLYCERIN (UNII: PDC6A3C0OX)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
CITRAL (UNII: T7EU0O9VPP)
HONEY (UNII: Y9H1V576FH)
LEMON PEEL (UNII: 72O054U628)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70939-004-02	200 in 1 BOX	05/07/2020
1		40 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 70939-004-01	200 in 1 BOX	05/07/2020
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 70939-004-03	200 in 1 BOX	05/07/2020
3		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 70939-004-04	200 in 1 BOX	05/07/2020
4		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 70939-004-05	150 in 1 BOX	05/07/2020
5		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 70939-004-06	100 in 1 BOX	05/07/2020
6		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 70939-004-07	100 in 1 BOX	05/07/2020
7		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 70939-004-08	48 in 1 BOX	05/07/2020
8		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 70939-004-09	24 in 1 BOX	05/07/2020
9		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 70939-004-10	400 in 1 BOX	05/07/2020
10		15 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(70939-004)