UNBLEMISH (BENZOYL PEROXIDE) LOTION [RODAN & FIELDS, LLC]

UNBLEMISH (BENZOYL PEROXIDE) LOTION [RODAN & FIELDS, LLC]
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NDC 14222-2000-2
Set ID f1c67c7f-0071-4b12-b50d-534839a8d01a
Category HUMAN OTC DRUG LABEL
Packager Rodan & Fields, LLC
Generic Name
Product Class
Product Number
Application Number PART333D
  • Drug Facts

  • Active ingredient

    Benzoyl Peroxide 5%

  • Purpose

    Acne treatment

  • Uses

    • For the treatment of acne.
    • Penetrates pores to control acne blemishes, pimples and blackheads.
    • Helps prevent new acne blemishes, pimples and blackheads from forming.
  • Warnings

    ​For external use only.

  • Do not use if you

    • Have very sensitive skin.
    • Are sensitive to benzoyl peroxide.
  • When using this product

    • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.
    • Avoid unnecessary sun exposure and use a sunscreen.
    • Avoid contact with the eyes, lips and mouth.
    • Avoid contact with hair and dyed fabrics, which may be bleached by this product.
    • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.  Irritation may be reduced by using the product less frequently or in a lower combination.
  • STOP USE

    Stop use and ask a doctor if irritation becomes severe.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Cleanse skin thoroughly before applying this product.
    • Dispense 1-2 pumps from each side.  Blend product and apply evenly over the entire face, avoiding the eye area.  Allow to penetrate skin.  Do not rinse off.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to twice daily as needed or as directed by a doctor.  If bothersome dryness or peeling occur reduce application to once a day or every other day and apply a moisturizer.
    • If going outside, apply sunscreen after using this product.  If irritation or sensitivity develop, stop use of both products and ask a doctor.
  • Other information

    You may report a serious adverse reaction to Rodan+Field​s®​, Attn: Product Development, 60 Spear Street, Suite 600, San Francisco, CA 94105.

  • Inactive ingredients

    Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Biosaccharide Gum-1, Carbomer, C13-14 Isoparaffin, Ceramide AP, Ceramide EOP, Ceramide NP, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Disodium EDTA, Disodium Oleamido MEA Sulfosuccinate, Glycerin, Laureth-7, Niacinamide, Panthenol, Phytosphingosine, Polyacrylamide, Punica Granatum Extract, Purified Water, Sodium Lauroyl Lactylate, Xanthan Gum, Yucca Glauca Root Extract

  • Principal Display Panel - Rodan+Fields

    Rodan+Fields

    Unblemish

    Dual Intensive Acne Treatment

    2 X 22.5 mL/0.76 Fl. Oz.

    rfunblemish

  • INGREDIENTS AND APPEARANCE
    UNBLEMISH 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2000
    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
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    CARBOMER 934 (UNII: Z135WT9208)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-7 (UNII: Z95S6G8201)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-2000-21 in 1 CARTON
    122.5 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2014
    Labeler - Rodan & Fields, LLC (051659584)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei LLC105803274manufacture(14222-2000) , analysis(14222-2000) , label(14222-2000)

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