Benzoyl Peroxide by Malezia LLC / Pharmco Laboratories Inc. Benzoyl Peroxide

Benzoyl Peroxide by

Drug Labeling and Warnings

Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by Malezia LLC, Pharmco Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BENZOYL PEROXIDE- benzoyl peroxide gel 
Malezia LLC

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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Benzoyl Peroxide

50 mL NDC: 77924-001-01

50 mL NDC: 77924-001-01

50 mL NDC: 77924-001-01

50 mL NDC: 77924-001-01

50 mL NDC: 77924-001-01

50 mL NDC: 77924-001-01

50 mL NDC: 77924-001-01

50 mL NDC: 77924-001-01

BENZOYL PEROXIDE 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77924-001(NDC: 58400-001)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77924-001-01	48 g in 1 TUBE; Type 0: Not a Combination Product	08/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/21/2020	10/07/2020

Labeler - Malezia LLC (123312045)

Registrant - Pharmco Laboratories Inc. (096270814)

Establishment
Name	Address	ID/FEI	Business Operations
Malezia LLC		123312045	repack(77924-001) , relabel(77924-001)

Revised: 10/2020

Document Id: b130469a-0fda-0d02-e053-2995a90afd30

34390-5

Set id: a8271ee4-ab4b-6084-e053-2995a90a617b

Version: 2

Effective Time: 20201008