Label: HEAD AND SHOULDERS ROYAL OILS INSTANT SOOTHE SCALP- pyrithione zinc lotion

  • NDC Code(s): 69423-309-12, 69423-309-50
  • 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 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.

    • section hair if needed. Remove cap and place nozzle directly

    onto the scalp.

    • pump to cover entire section of exposed scalp (may take 3 or

    more pumps.) Massage into scalp.

    • repeat to cover entire scalp. Do not rinse.

  • Inactive ingredients

    Water, niacinamide, PEG-40 hydrogenated castor oil, menthol, mentha piperita (peppermint) oil, mentha arvensis leaf oil, phenoxyethanol, caffeine, bis-PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, glycerin, fragrance, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine, ethylhexylglycerin.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 125 mL Carton

    head &
    shoulders ®
    pyrithione zinc dandruff treatment

    ROYAL OILS

    INSTANT SOOTHE

    SCALP ELIXIR

    with COOLING MENTHOL

    & PEPPERMINT OIL

    RELIEVES ITCHY*, DRY SCALP

    ALL DAY, NO-RINSE

    SCALP PROTECTION*

    SULFATE, PARABEN &

    DYE FREE

    4.2 FL OZ
    (125 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS ROYAL OILS INSTANT SOOTHE SCALP 
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-309
    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
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    CAFFEINE (UNII: 3G6A5W338E)  
    BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETOL (UNII: Q4R969U9FR)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-309-121 in 1 CARTON08/30/2018
    1125 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:69423-309-5050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/21/201905/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03208/30/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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