Label: RODAN AND FIELDS UNBLEMISH - ACNE MEDICATED- benzoyl peroxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 23, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients

    Benzoyl Peroxide   2.5%

     Warnings: For external use only. When using this product avoid unnecessary sun exposure and use sunscreen. If going outside, use a sunscreen; allow UNBLEMISH 4 TREAT to dry, then follow directions in the sunscreen labeling. If irritation or sensitivity develops, discontinue use of both products and consult a doctor. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Do not get into eyes. If excessive skin irritation develops or increase, discontinue use and consult a doctor.


    Purpose: For the treatment and prevention of acne blemishes and breakouts.

    Questions or Comments

    1-888-995-5656


  • PRINCIPAL DISPLAY PANEL

    Unblemish- Acne Medicated Lotion

    1 fl. oz./6 mL

    image of back labelimage of front label

  • INGREDIENTS AND APPEARANCE
    RODAN AND FIELDS  UNBLEMISH - ACNE MEDICATED
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56152-0010-21 in 1 BOX
    1NDC:56152-0010-130 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33301/01/2009
    Labeler - Cosmetic Enterprises (017701475)
    Registrant - Rodan & Fields, LLC. (051659584)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises017701475manufacture