Label: ACNE TREATMENT- dermaline 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 July 8, 2022

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  • ACTIVE INGREDIENT

    Sulfur Precipitated 10%....... Acne Medication

  • WHEN USING

    Uses:

    For the treatment of acne. Penetrates the pores and dries and clears pimples and blackheads. Helps to keep new pimples and blackheads from forming.

  • KEEP OUT OF REACH OF CHILDREN

    Warnings: External Use Only. Keep out of reach of children.

    Avoid direct contact with eyes. In case of eye contact, flush thoroughly with water. Discontinue use if irritation occurs.

  • DO NOT USE

    Do not use on wounds or damaged skin, with a bandage, with heating pad, over extensive areas of the body, on children under 16 years of age unless directed by a doctor. If pregnant or breast-feeding ask a health professional before use. In case of accidental ingestion, get medical help or contact a Poison Control center immediately.

  • WHEN USING

    Adults and children 16 years of age and older. Wash th affected area with mild soap and warm water and rinse thorougly. Apply to affected area not more than 3 to 4 times daily. Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age: consult a doctor.

  • INACTIVE INGREDIENT

    Cetyl/Stearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Polyethyleneglycol, Propyleneglycol, Propylparaben, Sorbitan Oleate, Water

  • OTHER SAFETY INFORMATION

    Store at controlled room temperature: 15- 30 degrees C (59-86 degree F). Do not expose to excessive heat.

  • QUESTIONS

    Questions? Dermaline USA, 1(800) 371-0171 Weekdays 9am to 4pm. Eastern

  • DOSAGE & ADMINISTRATION

    Adults and children 16 years of age and older. Wash th affected area with mild soap and warm water and rinse thorougly. Apply to affected area not more than 3 to 4 times daily. Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age: consult a doctor.

  • WARNINGS

    Warnings: External Use Only. Keep out of reach of children.

    Avoid direct contact with eyes. In case of eye contact, flush thoroughly with water. Discontinue use if irritation occurs.

  • INDICATIONS & USAGE

    Uses:

    For the treatment of acne. Penetrates the pores and dries and clears pimples and blackheads. Helps to keep new pimples and blackheads from forming.

  • PURPOSE

    Acne Medication

  • PRINCIPAL DISPLAY PANEL

    LabelLabel

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT 
    dermaline sulfur ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82165-108
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL 2-PALMITATE (UNII: PD789E82CQ)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82165-108-0270.9 g in 1 JAR; Type 0: Not a Combination Product04/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00604/15/2022
    Labeler - Dermaline USA corp (016069241)
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