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PR Benzoyl Peroxide Wash

PRTM Benzoyl Peroxide Wash Rev.1.4

Approved
Approval ID

9dfc4f2d-3945-40a8-b260-f11eb1b2c742

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 12, 2018

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 Wash

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42546-145
Product Classification
G
Generic Name
Benzoyl Peroxide Wash
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 12, 2018
FDA Product Classification

INGREDIENTS (17)

Benzoyl PeroxideActive
Quantity: 70 mg in 1 mL
Code: W9WZN9A0GM
Classification: ACTIB
aloeInactive
Code: V5VD430YW9
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATEInactive
Code: 5M1101WGSY
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
GREEN TEA LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
sodium lauroamphoacetateInactive
Code: SLK428451L
Classification: IACT
laureth-12Inactive
Code: OAH19558U1
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
magnesium aluminum silicateInactive
Code: 6M3P64V0NC
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
sodium coco-sulfateInactive
Code: 3599J29ANH
Classification: IACT

Drug Labeling Information

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/12/2018

INDICATIONS AND USAGE:
PRTM Benzoyl Peroxide Wash is indicated for the topical treatment of acne vulgaris.

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PR Benzoyl Peroxide Wash - FDA Drug Approval Details