Label: SULFADERM- sulfur ointment

  • 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 June 10, 2023

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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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    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 finalM00606/10/2023
    Labeler - Pharmadel LLC (030129680)
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