CLENZIDERM M.D. SYSTEM

Manufacturer
Valeant Pharmaceuticals North America LLC | Ei INC.
Effective date
2015-06-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:31:42

Label at a glance#

ProductCLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM
Active ingredientSALICYLIC ACID, BENZOYL PEROXIDE
Label structure27 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

Daily Care Foaming Cleanser

DRUG FACTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment gel

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne.
  • Dries up acne pimples.
  • Helps prevent new acne pimples.

Warnings

WARNINGS SECTION

OTC - DO NOT USE 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

butyl avocadate, cetyl hydroxyethylcellulose, cocamidopropyl betaine, disodium EDTA, ethoxydiglycol, ext. D&C Violet 2, fragrance, menthol, menthyl lactate, sodium laureth sulfate, sodium lauryl sulfate, water

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Pore Therapy

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

OTC - DO NOT USE 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.
  • 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°C –25°C (59°F –77°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, benzyl alcohol, ethoxydiglycol, ext. D&C Violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B (alcohol denat.), water

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Therapeutic Lotion

DRUG FACTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5%

Purpose

OTC - PURPOSE SECTION

Acne treatment lotion

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.

OTC - DO NOT USE SECTION

Do not use if you

  • 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 sensitivitydevelops, 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

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®

MEDICAL

A DIVISION OF VALEANT PHARMACEUTICALS

CLENZIderm M.D.™ SYSTEM

Acne Therapeutic System

This CLENZIderm M.D. SYSTEM includes:

• Daily Care Foaming Cleanser 4 fl. oz. (118 mL)

• Pore Therapy 5 fl. oz. (148 mL)

• Therapeutic Lotion 1.6 fl. oz. (47 mL)

Clenziderm M.D. System Kit Carton
Clenziderm M.D. System Kit Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-6103-012021-05-26C16284748780-19d75b9d0-463f-f424-e053-dadaa90a57ceCLENZIDERM M.D. SYSTEM
0187-6103-012020-01-31C16284748780-19d75b9d0-463f-f424-e053-dadaa90a57ceCLENZIDERM M.D. SYSTEM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM2
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ2
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLINACTIVE INGREDIENTKD6TZ2QICH2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W72
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338G2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K2
CETYL HYDROXYETHYLCELLULOSE (350000 MW)INACTIVE INGREDIENTT7SWE4S2TT2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX2
DICAPRYLYL ETHERINACTIVE INGREDIENT77JZM5516Z2
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02B2
DIMETHYL ISOSORBIDEINACTIVE INGREDIENTSA6A6V432S2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
EXT. D&C VIOLET NO. 2INACTIVE INGREDIENTG5UX3K07282
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ42
MENTHOLINACTIVE INGREDIENTL7T10EIP3A2
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7I2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP02
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2
SQUALANEINACTIVE INGREDIENTGW89575KF92
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 505 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSHAMPOO / TOPICAL0.1 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JLOTION / TOPICAL111 mgExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BGEL / TOPICAL2500 mgExact identifier — unii candidate
6 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS18 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY, METERED / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRALESIONAL20 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / VAGINAL0.05 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AMOUTHWASH / BUCCAL0.15 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates

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
7984c6be-f2ee-4de0-bd75-7d69837670ecd8dcb9c1-764c-4786-96cf-57f24f36ceda2015-06-08WarningsExact identifier
spl set id: d8dcb9c1-764c-4786-96cf-57f24f36ceda

Reported adverse events (FAERS/openFDA)#

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