Label: DANDRUFF SHAMPOO- pyrithione zinc lotion/shampoo

  • 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 July 30, 2010

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient                      Purpose

    Pyrithione Zinc   1%                          Anti-Dandruff

  • INDICATIONS & USAGE

    Use  helps prevent recurrence of flaking and itching associated with dandruff

  • WARNINGS

    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 as directed

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    • shake well • for maximum dandruff control, use every time you shampoo • wet hair, message onto scalp, rinse, repeat if desired
    • for best result use at least twice a week or as directed by doctor
  • INACTIVE INGREDIENT

    Inactive ingredients water, sodium laureth sulfate, glycol distearate, sodium lauryl sulfate, cocamidopropyl betaine, cocamide MEA,
    zinc carbonate, behentrimonium chloride, fragrance, magnesium sulfate, sodium benzoate, zinc chloride, sodium citrate, benzyl alcohol, sodium chloride, sodium hydroxide, blue 1, red 4
  • PRINCIPAL DISPLAY PANEL

    Compare to
    Head + Shoulders
    active ingredient
    Pyrithione Zinc
    Dandruff
    Shampoo
    Everyday Clean
    Everyday basi cleaning
    for Normal or Oily Hair
    14.2 FL OZ
    (420 mL)
    image of package label

  • INGREDIENTS AND APPEARANCE
    DANDRUFF SHAMPOO 
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-311
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ZINC (UNII: J41CSQ7QDS)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-311-15.42 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35805/19/1998
    Labeler - Cardinal Health (097537435)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!