Label: SULFADERM- sulfur ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • Drug Facts

    Drug Facts

  • Active ingredient & Purpose

    Active ingredient

    		Purpose
    Sulfur 10% ........................Acne treatment

  • Uses

    For the treatment of acne. Clears up acne:

    • blemishes
    • pimples
    • blackheads
    • whiteheads
  • Warnings

    For external use only. Avoid contact with the eyes.

    Do not use on

    • broken skin
    • large areas of the skin

    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.
    • apply only to areas with acne

    If pregnant or breast feeding,

    ask a health professional before use

    Keep out of the reach of children.

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

  • Directions

    • cleanse the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times daily
    • 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
  • Other information

    • store between (59-86°F) 15-30°C
    • don’t use if clear seal over cap is broken, torn, or missing
  • Inactive ingredients

    cetyostearyl alcohol, glycerin, glyceryl monostearate, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, polyethylene

    glycol, sorbitan monooleate, water

  • Distributed by:

    Pharmadel LLC

    New Castle, DE 19720

    +1-866-359-3478

  • Principal Display Panel

    PDP Sulfur

  • INGREDIENTS AND APPEARANCE
    SULFADERM 
    sulfur ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-379
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-379-0257 g in 1 JAR; Type 0: Not a Combination Product06/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00606/10/2023
    Labeler - Pharmadel LLC (030129680)
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