Label: SEA BREEZE ACTIVES CLEAR-PORE ASTRINGENT- salicylic acid liquid

  • 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 April 13, 2011

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  • Active ingredient

    Salicylic acid 2%

  • Purpose

    Acne medication

  • Uses

    • for the treatment of acne
    • clears blackheads
  • Warnings

    For external use only.

  • When using this product

    • and other topical acne medication at the same time or immediately following use of this product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor.
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Flammable,

    keep away from open fire or flame.

  • Directions

    • clean skin thoroughly before applying medication.
    • moisten a cotton ball and smooth the cotton ball over your face one to three times daily.
  • Inactive ingredients

    Benzoic acid, camphor, clove (eugenia caryophyllus) oil, eucalyptus globulus oil, Ext. violet 2, fragrance, glycerin, methyl propanediol, PPG-12-buteth-16, SD alcohol 40-B, sodium benzoate, water.

  • Questions or comments?

    1-800-487-7273 or visit us at www.seabreezeclean.com

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SEA BREEZE ACTIVES CLEAR-PORE ASTRINGENT 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-3020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CLOVE OIL (UNII: 578389D6D0)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41595-3020-1295 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D02/01/2003
    Labeler - Idelle Labs, Ltd (128822926)
    Registrant - Idelle Labs, Ltd (128822926)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marianna Industries, Inc.045570736MANUFACTURE
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