Label: TINTED ACNE TREATMENT- resorcinol 2.00% sulfur 8.00% cream

  • 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 1, 2018

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                                                 Purpose
    Resorcinol - 2.00%...............................................................................................Acne Treatment
    Sulfur - 8.00% .................................................................................................... Acne Treatment

  • PURPOSE

  • INDICATIONS & USAGE

    Use for the treatment of acne

  • WARNINGS

    Warnings
    For external use only
    Do not use • if you have very sensitive skin or 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. • rinse right away with water if it gets in eyes • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth • 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 concentration.
    Stop use and ask a doctor if skin irritation becomes severe

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions • cleanse the skin thoroughly before applying medication • cover the entire affected area
    with a thin layer one to three times a day • because excessive drying of the skin may occur, start with one
    application daily, then gradually increase to two or three 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. Allow product to dry, then follow direction in the sunscreen labeling. If
    sensitivity develops, discontinue use of both products and consult a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Alcohol Denat.
    Bentonite
    Fragrance
    Glyceryl Stearate SE
    Iron Oxides
    Isopropyl Myristate
    Methylparaben
    Propylene Glycol
    Propylparaben
    Simethicone
    Titanium Dioxide
    Water

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    TINTED ACNE TREATMENT 
    resorcinol 2.00% sulfur 8.00% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7783
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Resorcinol (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) Resorcinol2 g  in 100 g
    Sulfur (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) Sulfur8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Bentonite (UNII: A3N5ZCN45C)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7783-011 in 1 CARTON09/13/2017
    118 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/13/2017
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(0363-7783) , label(0363-7783)