Label: FACIAL CLEANSER- salicylic acid gel

  • NDC Code(s): 55878-105-22, 55878-105-24, 55878-105-54
  • 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 03/13

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

  • PURPOSE

    PURPOSE

    ACNE TREATMENT

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SALICYLIC ACID (0.5%)

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  • WARNINGS

    WARNINGS FOR EXTERNAL USE ONLY

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  • INDICATIONS & USAGE

    USE

    FOR THE TREATMENT OF ACNE

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  • 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.

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  • 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.

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  • WHEN USING

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

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  • DOSAGE & ADMINISTRATION

    Directions

    Wet your face and gently massage facial cleanser into skin for 10 - 15 seconds, avoiding contact with eyes. Thoroughly rinse your face with lukewarm water.

    • Wash the entire affected area 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.
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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, cocamidopropyl betaine, sodium olefin sulfonate, acrylate copolymer, triethanolamine, propylene glycol, polyquaternium-7, panthenol, phenoxyethanol, disodium EDTA, salvia officinalis (sage) leaf extract, citric acid, fragrance.

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  • QUESTIONS

    Questions?

    1-866-404-7656 or www.exposedskincare.com

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  • INGREDIENTS AND APPEARANCE
    FACIAL CLEANSER 
    salicylic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55878-105
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    COCAMIDOPROPYL BETAINE  
    SODIUM C18 OLEFIN SULFONATE  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)  
    TROLAMINE  
    PROPYLENE GLYCOL  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)  
    PANTHENOL  
    PHENOXYETHANOL  
    EDETATE DISODIUM  
    SALVIA OFFICINALIS FLOWERING TOP  
    ANHYDROUS CITRIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55878-105-54 1 in 1 BOX
    1 NDC:55878-105-24 120 mL in 1 BOTTLE
    2 NDC:55878-105-22 60 mL in 1 BOTTLE
    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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