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.

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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

73557-23173557-23373557-239

INSTANT HAND SANITIZER 
alcohol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-239
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL375 mL  in 500 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:73557-239-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/27/2020
INSTANT HAND SANITIZER 
alcohol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-233
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CLOVE (UNII: K48IKT5321)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73557-233-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/27/2020
INSTANT HAND SANITIZER 
alcohol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-231
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL45 mL  in 60 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:73557-231-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/27/2020
Labeler - Shanghai Chuangshi Industry Group Co., Ltd (546872672)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Chuangshi Industry Group Co., Ltd546872672manufacture(73557-231, 73557-233, 73557-239) , label(73557-231, 73557-233) , relabel(73557-239)

Revised: 4/2020
Document Id: a44e086a-1b4d-7d79-e053-2a95a90a8369
Set id: a44e086a-1b4c-7d79-e053-2a95a90a8369
Version: 1
Effective Time: 20200427
 
Shanghai Chuangshi Industry Group Co., Ltd