FDA.reportPublic FDA data

REPLENIX ACNE 10% WASH PARABEN FREE WITH ALOE

Manufacturer
Topiderm, Inc. | Topix Pharmaceuticals, Inc.
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:03:34

Label at a glance#

ProductREPLENIX ACNE 10% WASH PARABEN FREE WITH ALOE
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

SPL UNCLASSIFIED 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

Aloe Barbadensis Leaf Extract, Carbomer, Disodium EDTA, Fragrance, Maltodextrin, Phenoxyethanol, Purified Water, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Stearic Acid USP.

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REPLENiX®
ACNE SOLUTIONS

Acne Wash
with Aloe Vera

Benzoyl Peroxide USP, 10%

Net 6.7 fl. oz. (200 ml)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN5
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD5
142034benzoyl peroxide 10 % Medicated Liquid SoapSY5

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
51326-113-012022-10-12C16284748780-1ba0f9c33-3f18-a910-e053-dadaa90a0b85REPLENIX ® ACNE SOLUTIONS 10% WASH PARABEN FREE WITH ALOE
51326-113-012021-01-29C16284748780-1ba0f9c33-3f18-a910-e053-dadaa90a0b85REPLENIX ® ACNE SOLUTIONS 10% WASH PARABEN FREE WITH ALOE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-113-01REPLENIX ACNE 10% WASH PARABEN FREE WITH ALOE200 mL in 1 BOTTLE, PLASTICLIQUID2005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-113REPLENIX ACNE 10% WASH PARABEN FREE WITH ALOE (BENZOYL PEROXIDE) LIQUID [TOPIDERM, INC.]5Current NDC, Legacy NDC, 1 package rows20231207_ea9a32c4-3795-4718-9394-bac69091c732.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-11351326-113-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
MALTODEXTRIN7CVR7L4A2DIACT
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 10% WASH PARABEN FREE WITH ALOEBENZOYL PEROXIDETopiderm, Inc.ea9a32c4-3795-4718-9394-bac69091c7322023-12-04WarningsExact identifier
ndc (package): 51326-113-01
ndc (product): 51326-113
ndc11 (package): 51326011301
spl id: bc8e280f-d928-46b7-acd6-ec852f1a4efd
spl set id: ea9a32c4-3795-4718-9394-bac69091c732

Reported adverse events (FAERS/openFDA)#

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