Label: ACNE TREATMENT SULFUR WASH RODAN AND FIELD- sulfur liquid

  • 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 May 14, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient      Purpose

    Sulfur 3%                Acne treatment

    Uses

    For the treatment of acne

    Helps keep skin clear of new acne, blemishes, pimples, and blackheads.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

    Do not use on Broken skin or apply to large areas of the body

    for external use only.

    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 increases, discontinue use and consult a doctor.

    apply to affected areas only.

    wet skin with lukewarm water. Using fingertips, gently and evenly massage a quarter-sized amount onto entire face for 30-60 seconds, avoid contact with eyes.

    Rinse thoroughly; pat dry. use once daily and increase to twice daily as tolerated.

    Water, Sodium Laureth Sulfate, Distearyl Phthalic Acid Amide, Lauryl Glucoside, Hydrogenated Polyisobutene, Dissodecyl Adipate, Glycerin, Cetearyl Alcohol, Acacia Senegal Gum, Glyceryl Stearate, PEG-100 Stearate, Polyacrylamide, Cetyl Alcohol, Ceteareth-20, Magnesium Aluminum Silicate, Fragrance, C13-14 Isoparaffin, Bisabolol, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Xanthan Gum, Aloe Barnadensis Leaf Juice, Laureth-7, Camellia Oleifera Leaf Extract, Arnica Montana Flower Extrat, Blue 1, Violet 2, Titanium Dioxide, Red 33

  • PRINCIPAL DISPLAY PANEL

    image of box label

    image of bottle label

    Rodan and Fields

    Unblemish

    Dermatologist Developed Acne Treatment

    Sulfur Wash

    125 mL/ 4.2 Fl. Oz.

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT SULFUR WASH  RODAN AND FIELD
    sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ACACIA (UNII: 5C5403N26O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-2050-21 in 1 CARTON
    1NDC:14222-2050-1125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/08/2011
    Labeler - Rodan & Fields, LLC. (051659584)
    Registrant - Cosmetic Enterprises Ltd (017701475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises Ltd017701475manufacture(14222-2050)