Label: SULUR 8 KIDS ANTI-DANDRUFF HAIR AND SCALP CONDITIONER- 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 November 6, 2019

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

  • 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 consult a doctor if

    • conditions worsens or does not improve after regular use.

    Keep out of reach of children

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

  • Directions

    • shake well
    • for best results, use twice a week 
    • wet hair, apply shampoo, lather, rinse & repeat
  • Inactive Ingredients

    SD Alcohol 40, Water, Propylene Glycol, Benzyl Alcohol, Menthol.

  • Package Labeling:

    022-00

  • INGREDIENTS AND APPEARANCE
    SULUR 8 KIDS ANTI-DANDRUFF HAIR AND SCALP CONDITIONER 
    sulfur ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12022-022
    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)  
    SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 81 (UNII: 2MSF640LWM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12022-022-00113 g in 1 JAR; Type 0: Not a Combination Product08/20/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/20/1997
    Labeler - J. Strickland & Co. (007023112)
    Registrant - J. Strickland & Co. (007023112)
    Establishment
    NameAddressID/FEIBusiness Operations
    J. Strickland & Co.007023112manufacture(12022-022) , pack(12022-022) , label(12022-022)