FDA.reportPublic FDA data

CLENZIDERM THERAPEUTIC LOTION

Manufacturer
Obagi Cosmeceuticals LLC | G.S.COSMECEUTICAL USA, INC. | Denison Pharmaceuticals, LLC
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:57:06

Label at a glance#

ProductCLENZIDERM THERAPEUTIC
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Dosage and administration

Cleanse the skin thoroughly before applying this product Cover the entire affected area with a thin layer one to three times daily Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once a day or every other day If going outside, appl...

Storage and handling

Store away from heat and direct sunlight. Store at controlled room temperature: 15°–25°C (59°–77°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

  • for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

OTC - STOP USE SECTION

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation becomes severe.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Cleanse the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store away from heat and direct sunlight.
  • Store at controlled room temperature: 15°–25°C (59°–77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl benzoate, BHT, dicaprylyl ether, dimethyl isosorbide, disodium EDTA, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, phenoxyethanol, polysorbate 60, propylene glycol, squalane, water (aqua)

Questions or comments?

OTC - QUESTIONS SECTION

1.800.636.7546

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 47 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®
MEDICAL

CLENZIderm M.D.™

Therapeutic Lotion

Benzoyl Peroxide 5%
Acne Treatment

SoluZyl Technology® delivers
medication within the pores where
acne starts, helping to clear acne
quickly, in as early as one week.

1.6fl. oz. (47mL)

Principal Display Panel - 47 mL Bottle Label
Principal Display Panel - 47 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106309benzoyl peroxide 5 % Topical LotionPSN6
1236624Clenziderm Lotion 5 % Topical LotionPSN6
1236624benzoyl peroxide 50 MG/ML Topical Lotion [Clenziderm Lotion]SBD6
106309benzoyl peroxide 50 MG/ML Topical LotionSCD6
106309benzoyl peroxide 5 % Topical LotionSY6
1236624Clenziderm Lotion 5 % Topical LotionSY6
1236624Clenziderm Lotion 50 MG/ML Topical LotionSY6

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
62032-611-012025-03-12C16284748780-12cef2736-6f43-d83d-e063-dadaa90ab31fCLENZIDERM THERAPEUTIC LOTION
62032-611-012025-01-30C16284748780-12cef2736-6f43-d83d-e063-dadaa90ab31fCLENZIDERM THERAPEUTIC LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-611-01CLENZIDERM THERAPEUTIC47 mL in 1 BOTTLE, PLASTICLOTION476

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-611CLENZIDERM THERAPEUTIC (BENZOYL PEROXIDE) LOTION [OBAGI COSMECEUTICALS LLC]6Current NDC, Legacy NDC, 1 package rows20250315_f0ad29b6-38b0-4118-a711-3c668ac801ec.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-61162032-611-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
BENZYL BENZOATEN863NB338GIACT
DICAPRYLYL ETHER77JZM5516ZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
SQUALANEGW89575KF9IACT
POLYSORBATE 60CAL22UVI4MIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM7FLD91C86KIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
WATER059QF0KO0RIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clenziderm m.d. system acne therapeutic systemSALICYLIC ACID AND BENZOYL PEROXIDEObagi Cosmeceuticals LLC7710e51a-dd3a-4f44-8c97-c089c6817cb02025-03-19WarningsExact identifier
ndc (package): 62032-611-01
ndc11 (package): 62032061101
CLENZIDERM THERAPEUTICBENZOYL PEROXIDEObagi Cosmeceuticals LLCf0ad29b6-38b0-4118-a711-3c668ac801ec2025-01-01WarningsExact identifier
ndc (package): 62032-611-01
ndc (product): 62032-611
ndc11 (package): 62032061101
spl id: efbe8b81-ce80-489d-ba89-865a99d3b027
spl set id: f0ad29b6-38b0-4118-a711-3c668ac801ec

Reported adverse events (FAERS/openFDA)#

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