FDA.reportPublic FDA data

CLENZIDERM PORE THERAPY

Manufacturer
Valeant Pharmaceuticals North America LLC | Ei INC.
Effective date
2017-11-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:09:06

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 d...

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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

Distributed by Obagi Medical Products, a division of
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
®/TM are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates.
© OMP, Inc. www.obagi.com 9426302

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)

Clenziderm M.D. Pore Therapy 148 mL Bottle Label
Clenziderm M.D. Pore Therapy 148 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-6102-042021-05-07C16284748780-19d75b9d0-6e02-f424-e053-dadaa90a57ceOBAGI ® MEDICAL CLENZIderm M.D.™ Pore Therapy Refreshing CLENZIderm M.D.™ Pore Therapy unclogs and refines pores and clears away dead skin cells with 2% salicylic acid.
0187-6102-042020-01-31C16284748780-19d75b9d0-6e02-f424-e053-dadaa90a57ceOBAGI ® MEDICAL CLENZIderm M.D.™ Pore Therapy Refreshing CLENZIderm M.D.™ Pore Therapy unclogs and refines pores and clears away dead skin cells with 2% salicylic acid.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLINACTIVE INGREDIENTKD6TZ2QICH1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02B1
EXT. D&C VIOLET NO. 2INACTIVE INGREDIENTG5UX3K07281
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7I1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
0187-61020187-6102-04

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
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
EXT. D&C VIOLET NO. 2G5UX3K0728IACT
WATER059QF0KO0RIACT

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 4 · 238 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SOFT TISSUE23 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BCREAM / TOPICAL1290 mgExact identifier — unii candidate
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAMUSCULAR54 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AAEROSOL, METERED / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGUM, CHEWING / BUCCAL89 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / VAGINAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / ENDOTRACHEAL54 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / NASAL40.46 mg/100mlExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAMUSCULAR500 mgExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRALESIONAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact 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
dc5bdd85-23d3-4ed1-ad4c-e696de6a3adb37d89871-9a5f-4927-9c7d-a450ab56ac702017-11-30WarningsExact identifier
spl set id: 37d89871-9a5f-4927-9c7d-a450ab56ac70

Reported adverse events (FAERS/openFDA)#

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