Label: HEAD AND SHOULDERS CONDITIONER SMOOTH AND SILKY- pyrithione zinc lotion

  • NDC Code(s): 69423-103-10, 69423-103-25, 69423-103-31, 69423-103-38, view more
    69423-103-40, 69423-103-59, 69423-103-61, 69423-103-65, 69423-103-68, 69423-103-90
  • 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 April 4, 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.
    • apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.
  • Inactive ingredients

    Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, glutamic acid, dimethicone, fragrance, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 315 mL Tube Label

    head &

    shoulders ®

    pyrithione zinc dandruff conditioner

    smooth & silky
    HAIR & SCALP
    CONDITIONER

    24 hour frizz control from root to tip

    10.6 FL OZ (315 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS CONDITIONER  SMOOTH AND SILKY
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-103
    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
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-103-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/201612/22/2019
    2NDC:69423-103-68680 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/201609/08/2019
    3NDC:69423-103-9090 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/201601/15/2021
    4NDC:69423-103-65650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/11/201710/03/2020
    5NDC:69423-103-38380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/09/201810/31/2020
    6NDC:69423-103-1010 mL in 1 POUCH; Type 0: Not a Combination Product11/10/2017
    7NDC:69423-103-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/201807/20/2020
    8NDC:69423-103-61610 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/201809/01/2024
    9NDC:69423-103-31315 mL in 1 TUBE; Type 0: Not a Combination Product11/29/2018
    10NDC:69423-103-59592 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03211/10/2016
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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