Label: FRESH MINT DANDRUFF- pyrithione zinc shampoo

  • 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 January 17, 2020

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  • 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, message 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

  • principal display panel

    Dandruff Shampoo
    14.2 FL OZ (420 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    FRESH MINT DANDRUFF  
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-309-15.402 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2004
    2NDC:11344-309-21.088 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2004
    3NDC:11344-309-35.700 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2004
    4NDC:11344-309-391.0 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/21/2004
    Labeler - Vi Jon (150931459)
    Registrant - Vi Jon (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon088520668manufacture(11344-309)
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