Label: CLENZIDERM PORE THERAPY ACNE TREATMENT- salicylic acid liquid

  • NDC Code(s): 62032-612-04
  • Packager: Obagi Cosmeceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 19, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 2%

  • Purpose

    Acne treatment

  • Uses

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

    For external use only

    When using this product

    • 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 irritation becomes severe.

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

  • Directions

    • 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

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

    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?

    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

    OBAGI®
    MEDICAL

    CLENZIderm M.D.™

    Pore Therapy

    Salicylic Acid 2%
    Acne Treatment

    5 fl. oz. (148 mL)

    Principal Display Panel - 148 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CLENZIDERM PORE THERAPY   ACNE TREATMENT
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-612
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-612-04148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D02/01/2007
    Labeler - Obagi Cosmeceuticals LLC (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S.COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208MANUFACTURE(62032-612)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!