Label: DANDRUFF- pyrithione zinc lotion/shampoo

  • NDC Code(s): 53942-311-15, 53942-311-32
  • Packager: Demoulas Super Markets, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 2, 2023

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  • Claims

    Multiple benefit formula to help:

    • Fight dry scalp
    • Calm itch
    • Relieve irritation
    • Soothe and reduce redness
    • Reduce oiliness
    • Prevent flakes
    • Leave hair healthy looking
  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Use

    helps prevent recurrence of flaking and itching associated with dandruff

  • Warnings

    For external use only

  • When using this product

    • do not get into 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 as directed
  • Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well
    • for maximum dandruff control, use every time you shampoo
    • wet hair, massage onto scalp, rinse, repeat if desired
    • for best results use at least twice a week or as directed by a doctor
  • inactive ingredients

    water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

  • Disclaimer

    This product is not manufactured or distributed by Procter & Gamble, the distributor of Head & Shoulders® Classic clean 2in1 Dandruff Shampoo + Conditioner.

  • Adverse Reactions

    DISTRIBUTED BY

    DEMOULAS SUPER MARKETS, INC.

    875 EAST STREET

    TEWKSBURY, MA 01876

    MADE IN USE WITH US AND FOREIGN COMPONENTS

  • Principal display panel

    "MORE FOR YOUR DOLLAR"

    Market Basket®

    Dandruff

    Shampoo

    pyrithione zinc

    everyday clean

    For Normal/Oily Hair

    Compare to Head & Shoulders® 2in1 Classic Clean*

    12.5 FL OZ (370 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DANDRUFF  
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-311
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53942-311-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2009
    2NDC:53942-311-32370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03201/30/2009
    Labeler - Demoulas Super Markets, Inc (007869647)
    Registrant - Vi Jon, Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, Inc790752542manufacture(53942-311)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, Inc088520668manufacture(53942-311)
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