Label: ROYAL OILS BY HEAD AND SHOULDERS MOISTURE RENEWAL SCALP BALANCING CONDITIONER- pyrithione zinc lotion

  • NDC Code(s): 69423-571-40, 69423-571-93
  • 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 May 9, 2023

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  • 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.
    • for maximum dandruff control, use every time you shampoo.
    • gently massage into hair and scalp, rinse well.
  • Inactive ingredients

    Water, stearyl alcohol, dimethicone, behentrimonium chloride, cetyl alcohol, cocos nucifera (coconut) fruit extract, vinegar, zea mays (corn) silk extract, fragrance, phenoxyethanol, benzyl alcohol, citric acid, methylchloroisothiazolinone, methylisothiazolinone.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

    ROYAL OILS

    by head & shoulders ®
    pyrithione zinc dandruff conditioner

    MOISTURE RENEWAL

    SCALP BALANCING

    CONDITIONER

    ROYAL OILS

    WITH COCONUT OIL

    & APPLE CIDER VINEGAR

    13.5 FL OZ
    (400 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    ROYAL OILS BY HEAD AND SHOULDERS MOISTURE RENEWAL SCALP BALANCING CONDITIONER 
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-571
    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
    APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)  
    CORN SILK (UNII: 7D3VB244UX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COCONUT (UNII: 3RT3536DHY)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-571-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2021
    2NDC:69423-571-93930 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03205/01/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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