Label: PAULAS CHOICE CLEAR DAILY SKIN CLEARING TREATMENT- benzoyl peroxide lotion

  • 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 January 6, 2022

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  • ACTIVE INGREDIENT

    Benzoyl Peroxide 5%

  • PURPOSE

    Acne Treatment

  • INDICATIONS & USAGE

    • Treats acne.
    • Helps prevent new acne blemishes.
    • Penetrates pores to reduce acne blemishes.
  • DOSAGE & ADMINISTRATION

    After cleansing with Paula's Choice CLEAR Pore Normalizing Cleanser and exfoliating with Anti-Redness Exfoliating Solution, cover the affected area with a thin layer 1 to 3 times a day. Because excessive drying of the skin may occur, start with 1 appliation daily and then gradually increase to 2 or 3 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. If going outside, use a sunscreen. If sensitivity develops, discontinue use.

  • WARNINGS

    For external use only.

  • DO NOT USE

    Do not use · on broken skin · on large areas of the body · if you are sensitive to benzoyl peroxide.

  • ASK DOCTOR

    If too much skin irritation or skin sensitivity develops or increases.

  • WHEN USING

    · Avoid unnecessary sun exposure and use a sunscreen · Avoid contact with eyes, lips and mouthIf contact occure, rinse with water · This product may bleach hair or dyed fabrics · Using other topical acne products at the sam etime or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless direct by a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help and contact a Poison Control Center immediately.

  • STOP USE

    If too much skin irritation or skin sensitivity develops or increases.

  • OTHER SAFETY INFORMATION

    Store at 20-26ºC (68-77ºF). · You may report serious adverse reactions to 1030 SW 34th Street, Suite A, Renton, WA 98057.

  • INACTIVE INGREDIENT

    Water, Propulene Glycol, Bisabolol, Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymner, Hydroxyethylcellulose, Sodium Citrate, Laureth-4, Caprylyl Glycol, Hexylene Glycol, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PAULAS CHOICE CLEAR DAILY SKIN CLEARING TREATMENT 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76144-611
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)  
    LAURETH-4 (UNII: 6HQ855798J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76144-611-0167 mL in 1 TUBE; Type 0: Not a Combination Product09/07/2012
    2NDC:76144-611-0215 mL in 1 TUBE; Type 0: Not a Combination Product09/07/2012
    3NDC:76144-611-032 mL in 1 PACKET; Type 0: Not a Combination Product09/07/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/07/2012
    Labeler - Paula's Choice, LLC (029583981)
    Registrant - Paula's Choice, LLC (029583981)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thibiant International, Inc.083913913manufacture(76144-611)
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