Label: CLARIFYING MASK- sulfur and resorcinol paste

  • NDC Code(s): 55878-102-12
  • Packager: Halogent, LLC (DBA Exposed Skin Care)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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  • PURPOSE

    PURPOSE

    ACNE TREATMENT

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  • ACTIVE INGREDIENT

    ACTIVE INGRDIENT

    SULFUR (3.0%)

    RESORCINOL (2.0%)

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  • INDICATIONS & USAGE

    USE

    FOR THE TREATMENT OF ACNE

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  • WARNINGS

    WARNINGS FOR EXTERNAL USE ONLY

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  • WHEN USING

    When using this product

    • using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation. If this occurs, only one medication should be used unless directed by a doctor
    • apply only to areas with acne
    • do not get into eyes
    • do not use on broken skin or large areas of the skin
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  • STOP USE

    Stop use and ask a doctor if

    • SKIN IRRITATION OCCURS OR GET WORSE
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  • DOSAGE & ADMINISTRATION

    Directions

    Use 1 to 2 times per week

    • Clean the skin thoroughly before applying this product
    • Cover the entire affected area with a thin layer, leave on skin for 10-15 minutes, then rinse thoroughly with luke warm water, pat dry skin
    • Follow with a small amount of Clearing Tonic applied using bare hands.
    • If bothersome dryness or peeling occurs, reduce application to once per week.
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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, kaolin, bentonite, glyceryl stearate, peg-100 stearate, sesame oil, aluminum magnesium silicate, polysorbate 20, caprylyl glycol, phenoxyethanol, sorbic acid, aloe barbadensis leaf extract, vaccinium myrtillus extract, macrocystis pyriferae extract, carbomer, hydroxyethylcellulose, imidazolidinyl urea, caprylic/capric triglycerides, jojoba esters, helianthus annuus (sunflower) seed oil, hydrogenated polydecene, sodium polyacrylate, thioctic acid, dimethylethanolamine, ceramide 3, hyaluronic acid, collagen, retinyl palmitate.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • QUESTIONS

    Questions? 1-866-404-7656

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  • INGREDIENTS AND APPEARANCE
    CLARIFYING MASK 
    sulfur resorcinol paste
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55878-102
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SULFUR (SULFUR) SULFUR 3 g  in 100 mL
    RESORCINOL (RESORCINOL) RESORCINOL 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    KAOLIN  
    BENTONITE  
    GLYCERYL MONOSTEARATE  
    PEG-100 STEARATE  
    SESAME OIL  
    MAGNESIUM ALUMINUM SILICATE  
    POLYSORBATE 20  
    CAPRYLYL GLYCOL  
    PHENOXYETHANOL  
    SORBIC ACID  
    ALOE VERA LEAF  
    VACCINIUM MYRTILLUS WHOLE  
    MACROCYSTIS PYRIFERA  
    CARBOMER 940  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)  
    IMIDUREA  
    MEDIUM-CHAIN TRIGLYCERIDES  
    JOJOBA OIL  
    SUNFLOWER OIL  
    HYDROGENATED POLYDECENE (550 MW)  
    SODIUM POLYACRYLATE (8000 MW)  
    THIOCTIC ACID, (+)-  
    DEANOL  
    CERAMIDE 3  
    HYALURONIC ACID  
    COLLAGEN, SOLUBLE, FISH SKIN  
    VITAMIN A PALMITATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55878-102-12 50 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 02/07/2013
    Labeler - Halogent, LLC (DBA Exposed Skin Care) (790961697)
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