FDA.reportPublic FDA data

CLENZIDERM PORE THERAPY

Manufacturer
Obagi Cosmeceuticals LLC | G.S.COSMECEUTICAL USA, INC. | Denison Pharmaceuticals, LLC
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:57:02

Label at a glance#

ProductCLENZIDERM PORE THERAPY ACNE TREATMENT
Active ingredientSALICYLIC ACID
Label structure11 sections

Indications and uses

for the treatment of acne dries up acne pimples helps prevent new acne pimples

Dosage and administration

Cleanse the skin thoroughly before applying this product. Shake product well before use. 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 ever...

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

Salicylic acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of acne
  • dries up acne pimples
  • helps prevent new acne pimples

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.

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.
  • Shake product well before use.
  • 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.

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 alcohol, chamomilla recutita (matricaria) flower extract, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B, water (aqua)

Questions or comments?

OTC - QUESTIONS SECTION

1.800.636.7546 Monday–Friday 9a.m.–4p.m. Pacific Time

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®
MEDICAL

CLENZIderm M.D.™

Pore Therapy

Salicylic Acid 2%
Acne Treatment

5 fl. oz. (148 mL)

Principal Display Panel - 148 mL Bottle Label
Principal Display Panel - 148 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1235208CLENZIderm M.D. 2 % Pore Therapy Topical SolutionPSN3
251577salicylic acid 2 % Topical SolutionPSN3
1235208salicylic acid 20 MG/ML Topical Solution [Clenziderm]SBD3
251577salicylic acid 20 MG/ML Topical SolutionSCD3
1235208Clenziderm 20 MG/ML Topical SolutionSY3
1235208Clenziderm M.D. 2 % Pore TherapySY3
251577salicylic acid 2 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-612-042025-03-12C16284748780-12cef2736-72ee-d83d-e063-dadaa90ab31fCLENZIDERM PORE THERAPY ACNE TREATMENT
62032-612-042025-01-30C16284748780-12cef2736-72ee-d83d-e063-dadaa90ab31fCLENZIDERM PORE THERAPY ACNE TREATMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-612-04CLENZIDERM PORE THERAPYACNE TREATMENT148 mL in 1 BOTTLE, PLASTICLIQUID1483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-612CLENZIDERM PORE THERAPY ACNE TREATMENT (SALICYLIC ACID) LIQUID [OBAGI COSMECEUTICALS LLC]3Current NDC, Legacy NDC, 1 package rows20250315_08c1a55e-a376-4cd6-896f-0ad2068a1fc0.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-61262032-612-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
ALCOHOL3K9958V90MIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
BENZYL ALCOHOLLKG8494WBHIACT
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLKD6TZ2QICHIACT
CHAMOMILEFGL3685T2XIACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
EXT. D&C VIOLET NO. 2G5UX3K0728IACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Obagi Skintrinsiq Clarifiying ProtocolSALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDEObagi Cosmeceuticals LLC08ba9ea8-73fd-472b-9cc4-67df167352ec2025-03-21WarningsExact identifier
ndc (package): 62032-612-04
ndc11 (package): 62032061204
clenziderm m.d. system acne therapeutic systemSALICYLIC ACID AND BENZOYL PEROXIDEObagi Cosmeceuticals LLC7710e51a-dd3a-4f44-8c97-c089c6817cb02025-03-19WarningsExact identifier
ndc (package): 62032-612-04
ndc11 (package): 62032061204
CLENZIDERM PORE THERAPY ACNE TREATMENTSALICYLIC ACIDObagi Cosmeceuticals LLC08c1a55e-a376-4cd6-896f-0ad2068a1fc02025-01-01WarningsExact identifier
ndc (package): 62032-612-04
ndc (product): 62032-612
ndc11 (package): 62032061204
spl id: 7a1227cd-1bd0-4952-ae9e-d03d7c911b58
spl set id: 08c1a55e-a376-4cd6-896f-0ad2068a1fc0

Reported adverse events (FAERS/openFDA)#

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