Label: SULFUR 8 SCALP THERAPY MEDICATED DANDRUFF CONTROL SCALP BUTTER CREAM- sulfur, salicylic acid 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 November 6, 2019

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

  • Drug Facts

  • Active Ingredient

    Sulfur, 5%

    Salicylic Acid, 3%

    Purpose

    Antidandruff

  • Use

    • relieves the itching and scaling associated with dandruff
  • Warnings

    For external use only

    When using this product

    avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

    Stop use and consult a doctor if

    • condition worsens or does not improve after regular use as directed.
    • HAIR IS FLAMMABLE. Flammability is increased by product build-up. Keep hair away from sparks, flame, extreme heat or lit tobacco.

    Keep out of reach of children.

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

  • Directions

    • Apply a small amount to the scalp one to four times daily or as directed by a doctor.
  • Inactive Ingredients

    Petrolatum, Mineral Oil, Tribehenin, Arachidyl Propionate, Polysorbate 20, Fragrance

  • Package Labeling:

    3

  • INGREDIENTS AND APPEARANCE
    SULFUR 8 SCALP THERAPY MEDICATED DANDRUFF CONTROL SCALP BUTTER CREAM 
    sulfur, salicylic acid ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12022-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR50 mg  in 1 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12022-035-0099 g in 1 JAR; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/01/2020
    Labeler - J. Strickland and Co. (007023112)