Label: SULFUR 8 SCALP THERAPY MEDICATED DANDRUFF CONTROL SCALP OIL SERUM- sulfur suspension

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

Drug Label Information

Updated October 21, 2023

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

  • Drug Facts

  • Active Ingredient

    Sulfur, 2.5%

    Purpose

    Antidandruff

  • Use

    Controls scalp itching an flaking due to 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

    • if skin irritation develops or increases.
    • condition worsens or does not improve after regular use as directed.

    Keep out of reach of children.

    If swallowed, get medical help or call a Poison Control Center at once.

    Flammability is increased by proudct build-up. Keep hair away from sparks, flame, extreme heat or lit tobacco. Hair is Flammable.

  • Directions

    • Shake well before using.
    • For best results, use at least twice a week, or as directed by a doctor.
    • Before shampooing your hair, apply a small amount to the scalp in several areas. Rub in well. Wait 15 minutes. Shampoo thoroughly.
  • Inactive Ingredients

    Mineral Oil (Paraffinum Liquidum), Polysorbate 85, Disteardimonium Hectorite, Propylene Glycol, Benzyl Alcohol, Fragrance (Parfum)

  • Package Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    SULFUR 8 SCALP THERAPY MEDICATED DANDRUFF CONTROL SCALP OIL SERUM 
    sulfur suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12022-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 85 (UNII: A7F3N56197)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12022-034-001 in 1 BOX01/01/2020
    181 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03201/01/2020
    Labeler - J. Strickland and Co. (007023112)