Label: HEAD AND SHOULDERS CALMING LAVENDER DAILY HAIR AND SCALP CONDITIONER- pyrithione zinc lotion

  • NDC Code(s): 69423-320-31, 69423-320-38
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 March 31, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 0.5%

  • Purpose

    Anti-dandruff

  • Uses

    helps prevent recurrence of flaking and itching associated with 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 ask a doctor if

    • condition worsens or does not improve after regular use of this product as directed.

    Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • for best results use at least twice a week or as directed by a doctor.
    • apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.
  • Inactive ingredients

    Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, glutamic acid, dimethicone, fragrance, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride, lavandula angustifolia (lavender) flower extract,methylchloroisothiazolinone, methylisothiazolinone.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 325 mL Tube Label

    head &
    shoulders ®

    pyrithione zinc dandruff conditioner

    CALMING LAVENDER

    DAILY HAIR & SCALP

    CALMING CONDITIONER

    infused with LAVENDER + JASMINE ESSENCE

    10.6 FL OZ (315 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS CALMING LAVENDER  DAILY HAIR AND SCALP CONDITIONER
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-320
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-320-31315 mL in 1 TUBE; Type 0: Not a Combination Product01/08/201909/01/2024
    2NDC:69423-320-38380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/06/201801/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03208/06/201809/01/2024
    Labeler - The Procter & Gamble Manufacturing Company (004238200)