Label: SULFUR 8 LIGHT ANTI-DANDRUFF HAIR AND SCALP CONDITIONER- sulfur ointment

  • NDC Code(s): 12022-018-00, 12022-018-01, 12022-018-02
  • Packager: J. Strickland & Co.
  • 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

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  • Active Ingredients

    Sulfur, 2%

    Purpose

    Antidandruff

  • Use:

    Controls scalp itching and flaking due to dandruff

  • Warnings:

    For external use only

    When using this product

    • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • condition worsens or does not improve after regular use.

    If swallowed, get medical help or call a poison control center at once.

    • a gradual blue-black darking of the skin occurs
    • irritation becomes severe
    • no improvement is seen after 3 months
  • Directions

    • Apply to the affected area 1 - 4 times daily, or as directed by a doctor
  • Inactive Ingredients

    Petrolatum, Lanolin, Mineral Oil, Menthol, Fragrance, Yellow 11.

  • 12022-018-00

    018-00

  • 12022-018-01

    018-01

  • 12022-018-02

    018-02

  • INGREDIENTS AND APPEARANCE
    SULFUR 8 LIGHT ANTI-DANDRUFF HAIR AND SCALP CONDITIONER 
    sulfur ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12022-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MENTHOL (UNII: L7T10EIP3A)  
    D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12022-018-0057 g in 1 JAR; Type 0: Not a Combination Product12/01/1990
    2NDC:12022-018-01113 g in 1 JAR; Type 0: Not a Combination Product12/01/1990
    3NDC:12022-018-02205 g in 1 JAR; Type 0: Not a Combination Product12/01/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/01/1990
    Labeler - J. Strickland & Co. (007023112)
    Registrant - J. Strickland & Co. (007023112)
    Establishment
    NameAddressID/FEIBusiness Operations
    J. Strickland & Co.007023112manufacture(12022-018) , pack(12022-018) , label(12022-018)