Label: ACNE WIPEOUT CLEAR PORE OIL-FREE CLEANSER- benzoyl peroxide 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 October 2, 2020

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

  • Drug Facts

  • Active ingredient

    Benzoyl Peroxide 2.5% w/v

  • Purpose

    Acne treatment

  • Use

     • For the treatment of acne

  • Warnings

    For external use only.

    Do not use • If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation. Ask a doctor or pharmacist before use  If you are using other topical acne drugs at the same time or right after use of this product. This may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.

    When using this product Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.  Avoid unnecessary sun exposure and use a sunscreen.  Avoid product contact with hair and dyed fabrics, including towels, carpets and clothing which may be bleached by this product.

    Stop use and ask a doctor if
    excessive irritation occurs.

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 12 years of age and older:
    Use every morning and evening. Apply to damp skin and gently massage, avoiding the eye area. Rinse well. If bothersome dryness or irritation occurs, reduce frequency of use.

  • Other information

    • store at room temperature (68° to 77° F)
    • Protect from freezing

  • Inactive Ingredients

    Carbomer, Ethylhexylglycerin, Jojoba Esters, Phenoxyethanol, Sodium Hydroxide, Water, Silica, Sodium Dioctyl Sulfosuccinate, Xanthan Gum, 1,3 Propanediol, Dimethicone, PEG-40 Stearate.

  • QUESTIONS

    Questions? call toll free 855-299-8800

  • SPL UNCLASSIFIED SECTION

    DERMATOLOGICAL FIRST LINE ACNE CARE

    GENTLE EXFOLIATING JOJOBA GEL

    MICRONIZED 2.5% BENZOYL PEROXIDE ACNE WASH

    with shine control

    PART OF THE ACNE WIPEOUT CLINICAL ACNE SYSTEM

    acnewipeout.com

    made in usa

    UNIVERSITY MEDICAL

    PHARMACEUTICALS CORP

    9671 Irvine Center Drive

    Irvine, CA 92618

    ©2020

    NOT TESTED ON ANIMALS

    NON-COMEDOGENIC + FRAGRANCE FREE + PARABEN FREE + SULPHATE FREE

    CLEANSE + KEEP SKIN

    CALM + COMFORTABLE

    Gently clears pores to deliver medication as you clean, controls shine, calms redness and leaves skin feeling soft and smooth.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ACNE WIPEOUT CLEAR PORE OIL-FREE CLEANSER 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50544-151-001 in 1 CARTON06/01/2020
    1120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2020
    Labeler - University Medical Pharmaceuticals Corp. (809706252)