INSTANT HAND SANITIZER- alcohol hand sanitizer gel 
Shanghai Chuangshi Industry Group 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.

----------

INSTANT HAND SANITIZER, Alcohol 75%

Active Ingredient(s)

Ethyl alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable.

Keep away from heat or flame.

For external use only.

Do not use

When using this product, do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears or lasts.

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

Directions

Other information

Inactive ingredients

Water, Glycerin, Carbomer, Fragrance.

Package Label - Principal Display Panel

73557-23073557-23573557-237

INSTANT HAND SANITIZER 
alcohol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-237
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL262.5 mL  in 350 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CLOVE (UNII: K48IKT5321)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73557-237-01350 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/29/2020
INSTANT HAND SANITIZER 
alcohol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-235
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL168.75 mL  in 225 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CLOVE (UNII: K48IKT5321)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73557-235-01225 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/29/2020
INSTANT HAND SANITIZER 
alcohol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37.5 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CLOVE (UNII: K48IKT5321)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73557-230-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/29/2020
Labeler - Shanghai Chuangshi Industry Group Co., Ltd (546872672)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Chuangshi Industry Group Co., Ltd546872672manufacture(73557-230, 73557-235, 73557-237) , label(73557-230, 73557-235) , relabel(73557-237)

Revised: 4/2020
Document Id: a4734fbc-6b68-3d12-e053-2a95a90a3838
Set id: a4734fbc-6b67-3d12-e053-2a95a90a3838
Version: 1
Effective Time: 20200429
 
Shanghai Chuangshi Industry Group Co., Ltd