Label: ROYAL OILS BY HEAD AND SHOULDERS SCALP CARE DUAL PACK- pyrithione zinc kit

  • NDC Code(s): 69423-571-40, 69423-608-38, 84126-003-01
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 11, 2024

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  • SPL UNCLASSIFIED SECTION

    ROYAL OILS

    by head & shoulders
    SULFATE FREE

    SCALP CARE

    SHAMPOO

    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

    ROYAL OILS

    by head & shoulders
    MOISTURE RENEWAL SCALP BALANCING CONDITIONER

    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.
    • apply to wet hair after shampooing by gently massaging 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 - Kit

    ROYAL OILS

    by head & shoulders ®

    Shampoo & Conditioner Inside

    pyrithione zinc dandruff shampoo

    ROYAL OILS

    by head & shoulders

    SULFATE FREE

    SCALP CARE

    SHAMPOO

    ROYAL OILS

    by head & shoulders

    pyrithione zinc dandruff conditioner

    MOISTURE RENEWAL

    SCALP BALANCING

    CONDITIONER

    1 PYRITHIONE ZINC DANDRUFF

    SHAMPOO 12.8 FL OZ (380 mL)

    1 PYRITHIONE ZINC DANDRUFF

    CONDITIONER 13.5 FL OZ (400 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    ROYAL OILS BY HEAD AND SHOULDERS SCALP CARE DUAL PACK 
    pyrithione zinc kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84126-003
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84126-003-011 in 1 CELLO PACK05/01/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 380 mL
    Part 21 BOTTLE, PLASTIC 400 mL
    Part 1 of 2
    ROYAL OILS BY HEAD AND SHOULDERS SULFATE FREE SCALP CARE 
    pyrithione zinc shampoo
    Product Information
    Item 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
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    WATER (UNII: 059QF0KO0R)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIMETHICONOL (50000 CST) (UNII: R2285D73YT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-608-38380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03205/01/2021
    Part 2 of 2
    ROYAL OILS BY HEAD AND SHOULDERS MOISTURE RENEWAL SCALP BALANCING CONDITIONER 
    pyrithione zinc lotion
    Product Information
    Item 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
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    COCONUT (UNII: 3RT3536DHY)  
    CORN SILK (UNII: 7D3VB244UX)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-571-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03205/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03205/01/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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