FDA.reportPublic FDA data

REPLENIX ACNE SOLUTIONS WASH

Manufacturer
Topiderm, Inc. | Topix Pharmaceuticals, Inc.
Effective date
2019-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:02

Label at a glance#

ProductREPLENIX ACNE SOLUTIONS WASH
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Indications and uses

BP Wash is a therapeutic combination of sudsing cleanser and benzoyl peroxide for the treatment of acne.

Dosage and administration

Shake well. Wet affected area, wash, and rinse well. Use once or twice daily or as directed by a physician. If bothersome drying or peeling occurs, reduce applications. If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide USP, 10%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

BP Wash is a therapeutic combination of sudsing cleanser and benzoyl peroxide for the treatment of acne.

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

  • When using this product avoid unnecessary sun exposure and use a sunscreen.
  • For external use only.
  • Keep away from eyes, lips, and mouth.
  • If irritation or sensitivity develops, discontinue use and consult a doctor.
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • May bleach fabrics.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well. Wet affected area, wash, and rinse well.
  • Use once or twice daily or as directed by a physician.
  • If bothersome drying or peeling occurs, reduce applications.
  • If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Phenoxyethanol, Purified Water, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Stearic Acid USP.

PRINCIPAL DISPLAY PANEL - 200 ml Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REPLENiX®
ACNE SOLUTIONS

Acne Wash

Benzoyl Peroxide USP, 10%

Net 6.7 fl. oz. (200 ml)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

PRINCIPAL DISPLAY PANEL - 200 ml Tube Label
PRINCIPAL DISPLAY PANEL - 200 ml Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN3
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD3
142034benzoyl peroxide 10 % Medicated Liquid SoapSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51326-112-012021-11-19C16284748780-1ba0f9c33-21f1-a910-e053-dadaa90a0b85REPLENIX ® ACNE SOLUTIONS 10% WASH
51326-112-012021-01-29C16284748780-1ba0f9c33-21f1-a910-e053-dadaa90a0b85REPLENIX ® ACNE SOLUTIONS 10% WASH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-112-01REPLENIX ACNE SOLUTIONS WASH200 mL in 1 TUBELIQUID2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-112REPLENIX ACNE SOLUTIONS WASH (BENZOYL PEROXIDE) LIQUID [TOPIDERM, INC.]3Current NDC, Legacy NDC, 1 package rows20231201_8dc2d27d-3cc4-4874-b4c2-32607849b205.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-11251326-112-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REPLENIX ACNE SOLUTIONS WASHBENZOYL PEROXIDETopiderm, Inc.8dc2d27d-3cc4-4874-b4c2-32607849b2052019-12-17WarningsExact identifier
ndc (package): 51326-112-01
ndc (product): 51326-112
ndc11 (package): 51326011201
spl id: 76eb998f-5b37-4224-94f7-d47979f58542
spl set id: 8dc2d27d-3cc4-4874-b4c2-32607849b205

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.