HAND SANITIZER- alcohol gel 
Dongguang Shuoguo Silicone Products Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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70939-003 62% Alcohol Hand Sanitizer

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

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

1

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70939-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70939-003-02300 in 1 BOX05/07/2020
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70939-003-0148 in 1 BOX05/07/2020
2250 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:70939-003-03200 in 1 BOX05/07/2020
330 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:70939-003-04200 in 1 BOX05/07/2020
440 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:70939-003-05200 in 1 BOX05/07/2020
550 mL in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:70939-003-06200 in 1 BOX05/07/2020
660 mL in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:70939-003-07150 in 1 BOX05/07/2020
7100 mL in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:70939-003-08150 in 1 BOX05/07/2020
8120 mL in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:70939-003-0924 in 1 BOX05/07/2020
9500 mL in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:70939-003-1012 in 1 BOX05/07/2020
101000 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/06/2020
Labeler - Dongguang Shuoguo Silicone Products Co., Ltd. (544426629)
Establishment
NameAddressID/FEIBusiness Operations
Dongguang Shuoguo Silicone Products Co., Ltd.544426629manufacture(70939-003)

Revised: 5/2020
Document Id: a5044eee-ee58-b177-e053-2a95a90ac699
Set id: a5044eee-ee57-b177-e053-2a95a90ac699
Version: 1
Effective Time: 20200506
 
Dongguang Shuoguo Silicone Products Co., Ltd.