Label: HEAD AND SHOULDERS- 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 April 18, 2017

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  • WARNINGS

    WARNININGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    • Avoid contact with 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 of this product as directed.

  • INDICATIONS & USAGE

    DIRECTIONS

    • for maximum dandruff control, use every time you shampoo.
    • wet hair, message onto scalp, rinse, repeat if desired.
    • for best results use at least twice a week or as directed by a doctor.

  • ACTIVE INGREDIENT

    PYRITHIONE ZINC 1%

  • INACTIVE INGREDIENT

    Water,sodium laureth sulfate, sodium lauryl sulfate, cocamide mea, zinc carbonate, glycol distearate, dimethicone, fragance, guarhydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, sodium chloride, methylchloroisothiazolinone,methylisothiazolinone, sodium xylenesulfonate, blue 1, D&C red 33.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

  • PURPOSE

    PURPOSE

    Anti-drandruff

  • DOSAGE & ADMINISTRATION

    FOR EXTERNAL USE ONLY

    FOR BEST RESULTS USE A LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

  • PRINCIPAL DISPLAY PANEL

  • PRINCIPAL DISPLAY PANEL

    HEAD AND SHOULDER

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS 
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.01 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOHEXYL CINNAMATE (UNII: 2955WP594O)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    C.I. ACID BLUE 324 (UNII: QCA734O5N6)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-139-40400 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
    2NDC:69772-139-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
    3NDC:69772-139-20200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
    4NDC:69772-139-70700 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
    5NDC:69772-139-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
    6NDC:69772-139-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/23/2015
    Labeler - Teresa Cecena DBA Genesis (078760958)
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