BenzePrO
BenzePrO Foaming Cloths benzoyl peroxide 6.0%
Approved
Approval ID
8e13d1bb-a124-4ffd-8aed-aaab080b7535
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2022
Manufacturers
FDA
PruGen, Inc.
DUNS: 929922750
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzoyl Peroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42546-016
Product Classification
G
Generic Name
Benzoyl Peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 19, 2022
FDA Product Classification
INGREDIENTS (17)
waterInactive
Code: 059QF0KO0R
Classification: IACT
Benzoyl PeroxideActive
Quantity: 60 mg in 1 1
Code: W9WZN9A0GM
Classification: ACTIB
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked)Inactive
Code: 809Y72KV36
Classification: IACT
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Sodium Cocoyl IsethionateInactive
Code: 518XTE8493
Classification: IACT
Sodium Lauryl SulfoacetateInactive
Code: D0Y70F2B9J
Classification: IACT
Sodium Methyl Cocoyl TaurateInactive
Code: JVL98CG53G
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Disodium Laureth SulfosuccinateInactive
Code: D6DH1DTN7E
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Zinc LactateInactive
Code: 2GXR25858Y
Classification: IACT
Sodium Citrate, Unspecified FormInactive
Code: 1Q73Q2JULR
Classification: IACT
Docusate SodiumInactive
Code: F05Q2T2JA0
Classification: IACT
Hyaluronate SodiumInactive
Code: YSE9PPT4TH
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
Sodium Pyrrolidone CarboxylateInactive
Code: 469OTG57A2
Classification: IACT