Label: HEAD AND SHOULDERS CLASSIC CLEAN- pyrithione zinc shampoo

  • NDC Code(s): 37000-071-01, 37000-071-10, 37000-071-11, 37000-071-12, view more
    37000-071-25, 37000-071-37, 37000-071-40, 37000-071-50, 37000-071-61, 37000-071-70, 37000-071-83, 37000-071-90, 37000-071-95
  • 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 March 31, 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 lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, fragrance, cocamidopropyl betaine, sodium xylenesulfonate, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride,magnesium carbonate hydroxide, blue 1, red 33

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label

    head &

    shoulders ®
    pyrithione zinc dandruff shampoo

    classic clean

    DAILY SHAMPOO
    america's #1 dandruff shampoo**

    FLAKE FREE.*
    UP TO 100%
    GUARANTEED^

    12.5 FL OZ (370 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS  CLASSIC CLEAN
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-071
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-071-0110 mL in 1 POUCH; Type 0: Not a Combination Product09/01/2013
    2NDC:37000-071-5050 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
    3NDC:37000-071-70700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/201301/15/2025
    4NDC:37000-071-101000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/201310/04/2018
    5NDC:37000-071-111180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/201301/15/2019
    6NDC:37000-071-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/201301/15/2025
    7NDC:37000-071-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
    8NDC:37000-071-9090 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/10/2016
    9NDC:37000-071-95950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/10/201601/15/2025
    10NDC:37000-071-121280 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/201701/15/2025
    11NDC:37000-071-37370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2023
    12NDC:37000-071-61613 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2023
    13NDC:37000-071-83835 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03209/01/2013
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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