Label: DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 53942-281-15, 53942-281-32
  • Packager: Demoulas Super Markets, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • Claims

    Multiple benefit formula to help:

    • Fight dry scalp
    • Calm itch
    • Releive 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 exteral 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

    condtion 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, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

  • Dislcaimer

    This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders® Dry Scalp Care Dandruff Shampoo.

  • Adverse reactions

    DISTRIBUTED BY

    DEMOULAS SUPER MARKETS, INC

    875 EAST STREET

    TEWKSBURY, MA 01876

    MADE IN USA WITH US AND FOREIGN COMPONENTS

  • principal display panel

    "MORE FOR YOUR DOLLAR"

    MARKET BASKET

    Dandruff Shampoo

    pyrithione zinc

    dry scalp

    Moisture balancing for dry scalp relief with added almond oil

    Compare to Head & Shoulders® Dry Scalp Care®*

    12.5 FL OZ (370mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-281
    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)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53942-281-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2009
    2NDC:53942-281-32370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2023
    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 (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(53942-281)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(53942-281)
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