DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS, LLC]

DANDRUFF (PYRITHIONE ZINC) SHAMPOO [DZA BRANDS, LLC]
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NDC 55316-017-15
Set ID 6f22b5e3-bc32-43eb-8bfc-c42317f19dd2
Category HUMAN OTC DRUG LABEL
Packager DZA BRANDS, llc
Generic Name
Product Class
Product Number
Application Number PART358H
  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Use

    helps prevent recurrence of flaking and itching assocaited 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, sodim benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

  • SPL UNCLASSIFIED SECTION

    healthy accents
    smooth spice dandruff shampoo plus conditioner
    pyrithione zinc

    *This product is not manufactured or distributed by the Procter & Gamble Company, distributor of Head & Shoulders Dandruff Shampoo & Conditioner Old Spice Men 2 in 1

    DISTRIBUTED BY: DZA BRANDS, LLC
    2110 Execitve Drive, Salisbury, NC 28147
    1-866-322-2439

  • principal display panel

    healthy accents

    smooth spice dandruff shampoo plus conditioner

    pyritione zinc

    2 in 1 For Men

    an energizing clean enhanced with a masculine scent

    *compare to Head & Shoulders Dandruff Shampoo + Conditioner Old Spice Men 2 in 1

    14.2 FL OZ (420 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-017
    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:55316-017-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/20/2015
    Labeler - DZA BRANDS, llc (090322194)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55316-017)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55316-017)

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