Label: ROYAL OILS BY HEAD AND SHOULDERS MOISTURE BOOST SCALP CARE- pyrithione zinc shampoo

  • NDC Code(s): 69423-570-01, 69423-570-40, 69423-570-93
  • 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 8, 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, sodium laureth sulfate, dimethicone, zinc carbonate, glycol distearate, cocamide MEA, cocamidopropyl betaine, sodium chloride, sodium xylenesulfonate, fragrance, cocos nucifera (coconut) oil, vinegar†, guar hydroxypropyltrimonium chloride, sodium benzoate, polyquaternium-10, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, 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 SHAMPOO

    MOISTURE BOOST

    SCALP CARE

    SHAMPOO

    WITH COCONUT OIL

    & APPLE CIDER VINEGAR

    REFRESHES & PROMOTES

    HEALTHY HAIR

    13.5 FL OZ (400 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    ROYAL OILS BY HEAD AND SHOULDERS MOISTURE BOOST SCALP CARE 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-570
    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
    ACETIC ACID (UNII: Q40Q9N063P)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-570-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2021
    2NDC:69423-570-012 in 1 CELLO PACK05/01/202105/01/2023
    2400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:69423-570-93930 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/202103/01/2024
    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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