Label: ROYAL OILS BY HEAD AND SHOULDERS SULFATE FREE SCALP CARE- pyrithione zinc shampoo

  • NDC Code(s): 69423-608-38
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 1%

  • 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.
    • for maximum dandruff control, use every time you shampoo.
    • shake before use.
    • wet hair, massage onto scalp, rinse, repeat if desired.
  • Inactive ingredients

    Water, lauramidopropyl betaine, sodium cocoyl isethionate, sodium lauroyl sarcosinate, sodium citrate, fragrance, sodium chloride, cocos nucifera (coconut) oil, vinegar†, acrylates copolymer, polyquaternium-10, dimethiconol, sodium benzoate, citric acid, sodium salicylate.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

    ROYAL OILS

    by head & shoulders ®

    PYRITHIONE ZINC DANDRUFF SHAMPOO

    SULFATE FREE

    SCALP CARE

    SHAMPOO

    WITH COCONUT OIL

    & APPLE CIDER VINEGAR

    12.8 FL OZ (380 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    ROYAL OILS BY HEAD AND SHOULDERS SULFATE FREE SCALP CARE 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-608
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONOL GUM (UNII: 4MJ9GU3T1P)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-608-38380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03210/30/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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