Label: CLEAR PORE SERUM- salicylic acid gel

  • 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 13, 2013

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  • PURPOSE

    PURPOSE

    ACNE TREATMENT

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SALICYLIC ACID (1.0%)

  • INDICATIONS & USAGE

    USE

    FOR THE TREATMENT OF ACNE

  • WARNINGS

    WARNINGS FOR EXTERNAL USE ONLY

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • DOSAGE & ADMINISTRATION

    Directions

    Gently apply a small amount of serum to affected area using your bare hands. Avoid contact with eyes.

    • Cleanse the skin thoroughly before applying medication
    • 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.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, hamamelis virginiana (witch hazel) distillate, glycerin, propylene glycol, peg 120 methyl glucose dioleate, polyquaternium-37, hydrogenated polydecene, tricedeth-6, spiraea ulmaria (meadowsweet) extract, glycyrrhiza glabra (licorice) root extract, ocimum basilicum extract , camellia sinensis (green tea) leaf extract, panthenol, phenoxyethanol, fragrance.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN, IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • QUESTIONS

    Questions? 1-866-404-7656

  • PRINCIPAL DISPLAY PANEL

    Retail_CPS

    CPS_new

  • INGREDIENTS AND APPEARANCE
    CLEAR PORE SERUM 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55878-103
    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
    WATER (UNII: 059QF0KO0R)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    LICORICE (UNII: 61ZBX54883)  
    OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55878-103-521 in 1 BOX
    1NDC:55878-103-1250 mL in 1 TUBE
    2NDC:55878-103-1126 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/07/2013
    Labeler - Halogent, LLC (DBA Exposed Skin Care) (790961697)
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