FDA.reportPublic FDA data

Replenix ® Acne Gel 5%

Manufacturer
Topiderm, Inc | Topiderm, Inc. | Topix Pharmaceuticals, Inc.
Effective date
2019-10-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:13

Label at a glance#

ProductReplenix Acne
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Indications and uses

Topical acne medication.

Dosage and administration

Cleanse the skin thoroughly before applying. Apply a thin layer daily, then gradually increase to two or three times daily. 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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide, USP 5%

Purpose

OTC - PURPOSE SECTION

Anti-acne

Uses

INDICATIONS & USAGE SECTION

  • Topical acne medication.

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

  • When using this product avoid unnecessary sun exposure and use a sunscreen.

SPL UNCLASSIFIED SECTION

  • For external use only.
  • Keep away from eyes, lips, and mouth.

SPL UNCLASSIFIED SECTION

  • If irritation develops, discontinue use and consult a doctor.

SPL UNCLASSIFIED SECTION

  • 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, consult 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

  • Cleanse the skin thoroughly before applying.
  • Apply a thin layer daily, then gradually increase to two or three times daily.
  • 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, Purified Water, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Stearic Acid.

PRINCIPAL DISPLAY PANEL - 57 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REPLENiX®
ACNE SOLUTIONS

Acne Gel
Benzoyl Peroxide USP, 5%
Net wt. 2 oz. (57 g)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

PRINCIPAL DISPLAY PANEL - 57 g Tube Label
PRINCIPAL DISPLAY PANEL - 57 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308694benzoyl peroxide 5 % Topical GelPSN3
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD3
308694benzoyl peroxide 5 % Topical GelSY3

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
51326-411-572023-10-17C16284748780-1f386c649-b378-0266-e053-dadaa90a7c1aReplenix ® Acne Gel 5%
51326-411-572023-01-30C16284748780-1f386c649-b378-0266-e053-dadaa90a7c1aReplenix ® Acne Gel 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-411-57Replenix Acne57 g in 1 TUBEGEL573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-411REPLENIX ACNE (BENZOYL PEROXIDE) GEL [TOPIDERM, INC]3Current NDC, Legacy NDC, 1 package rows20231108_03d4c298-8f44-41f7-b086-96ae836152bb.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-41151326-411-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
SODIUM HYDROXYMETHYLGLYCINATEDIG6BWZ9XTIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
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 AcneBENZOYL PEROXIDETopiderm, Inc03d4c298-8f44-41f7-b086-96ae836152bb2019-10-31WarningsExact identifier
ndc (package): 51326-411-57
ndc (product): 51326-411
ndc11 (package): 51326041157
spl id: 3f4c6873-4988-477e-b77e-0d4d981eb76d
spl set id: 03d4c298-8f44-41f7-b086-96ae836152bb

Reported adverse events (FAERS/openFDA)#

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