Label: FACIAL CLEANSER- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL

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 (0.5%)

  • WARNINGS

    WARNINGS FOR EXTERNAL USE ONLY

  • INDICATIONS & USAGE

    USE

    FOR THE TREATMENT OF ACNE

  • 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.

  • 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.

  • WHEN USING

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

  • 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.
  • 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.

  • QUESTIONS

    Questions?

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

  • PRINCIPAL DISPLAY PANEL

    FC_newRetail_FC

  • INGREDIENTS AND APPEARANCE
    FACIAL CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55878-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM C18 OLEFIN SULFONATE (UNII: Z6CI2A44YH)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55878-105-541 in 1 BOX
    1NDC:55878-105-24120 mL in 1 BOTTLE
    2NDC:55878-105-2260 mL in 1 BOTTLE
    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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