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

  • 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, 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.

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

  • 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 finalpart358H01/01/2020
    Labeler - J. Strickland and Co. (007023112)