ANTIBACTERIAL HAND SANITIZER- alcohol hand sanitizer gel 
Logomark Inc

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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Logomark, Hand Sanitizer, Gel, Alcohol 75%

Active Ingredient(s)

Ethyl alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Antibacterial

Use

For handwashing to decrease bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

Do not use

For external use only.

When using this product avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and continues for 72 hours.

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

76806-10176806-10476806-106

ANTIBACTERIAL HAND SANITIZER 
alcohol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76806-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL177.75 mL  in 237 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:76806-104-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/30/2020
ANTIBACTERIAL HAND SANITIZER 
alcohol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76806-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL266.25 mL  in 355 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:76806-106-01355 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/30/2020
ANTIBACTERIAL HAND SANITIZER 
alcohol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76806-101
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:76806-101-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/30/2020
Labeler - Logomark Inc (829978766)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Chuangshi Industry Group Co., Ltd546872672manufacture(76806-101, 76806-104, 76806-106)
Establishment
NameAddressID/FEIBusiness Operations
Logomark Inc829978766label(76806-101, 76806-104, 76806-106)

Revised: 4/2020
Document Id: a485c544-4b7f-eb06-e053-2a95a90ad22e
Set id: a485c544-4b7e-eb06-e053-2a95a90ad22e
Version: 1
Effective Time: 20200430
 
Logomark Inc