SINOGE- sanitizing gel gel 
Guangzhou Ouzhuang Biological Technology 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.

----------

Guangzhou Sinoge Gel

Active Ingredient(s)

Alcohol 75%

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Other information

Inactive ingredients

aloe barbadensis leaf extract, fragrant Orchid, propylene glycol, carbomer, triethanolamine, purified water

Package Label - Principal Display Panel

1000 mL NDC: 77598-128-06

1000 mL NDC: 77598-128-06

SINOGE 
sanitizing gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77598-128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GYMNADENIA CONOPSEA WHOLE (UNII: TF911C619B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77598-128-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
2NDC:77598-128-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
3NDC:77598-128-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
4NDC:77598-128-04300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
5NDC:77598-128-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
6NDC:77598-128-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
7NDC:77598-128-073800 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
8NDC:77598-128-085000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/15/2020
Labeler - Guangzhou Ouzhuang Biological Technology Co Ltd (418234821)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Ouzhuang Biological Technology Co Ltd418234821manufacture(77598-128)

Revised: 7/2020
Document Id: ab8751e2-5d68-4f3a-e053-2a95a90aa5e0
Set id: ab8751e2-5d69-4f3a-e053-2a95a90aa5e0
Version: 2
Effective Time: 20200728
 
Guangzhou Ouzhuang Biological Technology Co Ltd