clenziderm m.d. system

Manufacturer
Obagi Cosmeceuticals LLC | G.S.COSMECEUTICAL USA, INC. | Denison Pharmaceuticals, LLC
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:57:30

Label at a glance#

Productclenziderm m.d. system acne therapeutic system
Active ingredientSALICYLIC ACID, BENZOYL PEROXIDE
Label structure29 sections

Indications and uses

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

Dosage and administration

Cleanse the entire affected area with a thin layer and rinse thoroughly 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.

Storage and handling

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 entire affected area with a thin layer and rinse thoroughly 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°C–25°C (59°F– 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

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

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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.
  • Place a cotton ball or pad over the pump well and pump 2 to 3 times to saturate, then cover the entire affected area with a thin layer one to three times daily.
  • Allow the product to air-dry completely; do not rinse off.
  • 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°C–25°C (59°F– 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

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 5%

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
  • 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.

Do not use if you

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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°C–25°C (59°F– 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

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

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC,
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®
MEDICAL

CLENZIderm M.D.® SYSTEM

Acne Therapeutic System

This CLENZIderm M.D. SYSTEM includes:

  • (1) Daily Care Foaming Cleanser 4 FL. OZ. (118 mL)
  • (1) Pore Therapy 5 FL. OZ. (148 mL)
  • (1) Therapeutic Lotion 1.6 FL. OZ. (47 mL)
PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2191891{1 (47 ML) (benzoyl peroxide 50 MG/ML Topical Lotion) / 1 (118 ML) (salicylic acid 20 MG/ML Medicated Liquid Soap) / 1 (148 ML) (salicylic acid 20 MG/ML Topical Solution) } PackGPCK3
106309benzoyl peroxide 5 % Topical LotionPSN3
1236624Clenziderm Lotion 5 % Topical LotionPSN3
1235205CLENZIderm M.D. 2 % Medicated Liquid SoapPSN3
1235208CLENZIderm M.D. 2 % Pore Therapy Topical SolutionPSN3
562600salicylic acid 2 % Medicated Liquid SoapPSN3
251577salicylic acid 2 % Topical SolutionPSN3
2191891salicylic acid 2 % Topical Solution (148 ML) / benzoyl peroxide 5 % MG/ML Topical Lotion (47 ML) / salicylic acid 2 % Medicated Liquid Soap (118 ML) PackPSN3
1236624benzoyl peroxide 50 MG/ML Topical Lotion [Clenziderm Lotion]SBD3
1235205salicylic acid 20 MG/ML Medicated Liquid Soap [Clenziderm]SBD3
1235208salicylic acid 20 MG/ML Topical Solution [Clenziderm]SBD3
106309benzoyl peroxide 50 MG/ML Topical LotionSCD3
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD3
251577salicylic acid 20 MG/ML Topical SolutionSCD3
106309benzoyl peroxide 5 % Topical LotionSY3
1235205Clenziderm 20 MG/ML Medicated Liquid SoapSY3
1235208Clenziderm 20 MG/ML Topical SolutionSY3
1236624Clenziderm Lotion 5 % Topical LotionSY3
1236624Clenziderm Lotion 50 MG/ML Topical LotionSY3
1235205Clenziderm M.D. 2 % Daily Care CleanserSY3
1235208Clenziderm M.D. 2 % Pore TherapySY3
562600salicylic acid 2 % Facial Cleanser TonerSY3
562600salicylic acid 2 % Facial ScrubSY3
562600salicylic acid 2 % Medicated Liquid SoapSY3
251577salicylic acid 2 % Topical SolutionSY3
2191891salicylic acid 2 % Topical Solution (148 ML) / benzoyl peroxide 5 % MG/ML Topical Lotion (47 ML) / salicylic acid 2 % Medicated Liquid Soap (118 ML) PackSY3

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-610-11clenziderm m.d. systemacne therapeutic system118 mL in 1 BOTTLE, PLASTICLIQUID118 mL20 mg in 1mL3
62032-611-01clenziderm m.d. systemacne therapeutic system47 mL in 1 BOTTLE, PLASTICLOTION47 mL50 mg in 1mL3
62032-612-04clenziderm m.d. systemacne therapeutic system148 mL in 1 BOTTLE, PLASTICLIQUID148 mL20 mg in 1mL3
62032-613-01clenziderm m.d. systemacne therapeutic system1 in 1 CARTONKIT13
62032-613-09clenziderm m.d. systemacne therapeutic system1 in 1 CARTONKIT13
62032-613-15clenziderm m.d. systemacne therapeutic system1 in 1 CARTONKIT13
62032-613-15clenziderm m.d. systemacne therapeutic system1 in 1 BAGKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-610CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [OBAGI COSMECEUTICALS LLC]3Current NDC, Legacy NDC20250322_7710e51a-dd3a-4f44-8c97-c089c6817cb0.zip
62032-611CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [OBAGI COSMECEUTICALS LLC]3Current NDC, Legacy NDC20250322_7710e51a-dd3a-4f44-8c97-c089c6817cb0.zip
62032-612CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [OBAGI COSMECEUTICALS LLC]3Current NDC, Legacy NDC20250322_7710e51a-dd3a-4f44-8c97-c089c6817cb0.zip
62032-613CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM (SALICYLIC ACID AND BENZOYL PEROXIDE) KIT [OBAGI COSMECEUTICALS LLC]3Current NDC, Legacy NDC, 7 package rows20250322_7710e51a-dd3a-4f44-8c97-c089c6817cb0.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

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 · 5 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): 62032-613-09
ndc (package): 62032-613-15
ndc (package): 62032-612-04
ndc (package): 62032-613-01
ndc (package): 62032-610-11
ndc (package): 62032-611-01
ndc (product): 62032-613
ndc11 (package): 62032061011
ndc11 (package): 62032061101
ndc11 (package): 62032061315
ndc11 (package): 62032061301
ndc11 (package): 62032061204
ndc11 (package): 62032061309
spl id: bab0a250-f922-44f7-bd9e-517ebeb25fa7
spl set id: 7710e51a-dd3a-4f44-8c97-c089c6817cb0
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
CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENTSALICYLIC ACIDObagi Cosmeceuticals LLC268bf278-3f18-4410-b552-25baadb9f96c2025-01-01WarningsExact identifier
ndc (package): 62032-610-11
ndc (product): 62032-610
ndc11 (package): 62032061011
CLENZIDERM THERAPEUTICBENZOYL PEROXIDEObagi Cosmeceuticals LLCf0ad29b6-38b0-4118-a711-3c668ac801ec2025-01-01WarningsExact identifier
ndc (package): 62032-611-01
ndc (product): 62032-611
ndc11 (package): 62032061101

Reported adverse events (FAERS/openFDA)#

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