Label: HEAD AND SHOULDERS ROYAL OILS DAILY MOISTURE SCALP- pyrithione zinc cream

  • NDC Code(s): 69423-307-15
  • 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 July 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 0.1%

  • 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

    • Apply to affected areas one to four times daily or as directed by a doctor.

    • Twist the cap open. Place tip directly onto scalp (damp or dry)

    • Gently squeeze the bottle while moving tip fromfront to back of your scalp. Repeat to cover your entire scalp.

    • Massage for even distribution. Do not rinse.

  • Inactive ingredients

    Water, cocos nucifera (coconut) oil, cetyl alcohol, stearamidopropyl dimethylamine, fragrance, stearyl alcohol, quaternium-18, hydroxyethylcellulose, phenoxyethanol, benzyl alcohol, dimethicone, PEG-2M, cetearyl alcohol, methylparaben, propylparaben, oleyl alcohol, glyceryl stearate, citric acid, polysorbate 60.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label

    head &
    shoulders ®
    pyrithione zinc dandruff treatment

    ROYAL OILS

    DAILY MOISTURE

    SCALP CREAM

    WITH COCONUT OIL

    MOISTURIZES SCALP TO

    PREVENT DRYNESS AND ITCH*

    SULFATE, DYE &

    MINERAL OIL FREE

    5.0 FL OZ
    (150 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS ROYAL OILS DAILY MOISTURE SCALP 
    pyrithione zinc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    POLYETHYLENE OXIDE 100000 (UNII: V46Y6OJ5QB)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    QUATERNIUM-18 (UNII: O7757NO1VL)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-307-15150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03208/30/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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