BENZOYL PEROXIDE- benzoyl peroxide gel 
Malezia LLC

----------

Benzoyl Peroxide

50 mL NDC: 77924-002-01

Front label of Malezia Benzoyl Peroxide Gel

Back label for benzoyl peroxide gel

50 mL NDC: 77924-002-01

dosage and adminstration

50 mL NDC: 77924-002-01

Warning section

50 mL NDC: 77924-002-01

inactive ingredients

50 mL NDC: 77924-002-01

active ingredient

50 mL NDC: 77924-002-01

purpose

50 mL NDC: 77924-002-01

indications and usage

50 mL NDC: 77924-002-01

children warning

BENZOYL PEROXIDE 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77924-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
PROPANEDIOL (UNII: 5965N8W85T)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77924-002-0250000 mg in 1 TUBE; Type 0: Not a Combination Product12/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00608/21/2020
Labeler - Malezia LLC (123312045)
Establishment
NameAddressID/FEIBusiness Operations
Malezia LLC123312045label(77924-002) , manufacture(77924-002) , pack(77924-002)

Revised: 1/2024
Document Id: 1035ae00-c599-9660-e063-6394a90a2cc6
Set id: b1304464-bd7e-fb5d-e053-2995a90a54c4
Version: 6
Effective Time: 20240130
 
Malezia LLC