Label: 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 September 25, 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 controll, 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, Mentha piperita (peppermint) oil, Mentha arvensis leaf oil, Melaleuca alternifolia (tea tree) leaf oil, citric acid, methylchloroisothiazolinone, methylisothiazolinone, hydroxycitronellal, linalool, blue 1, yellow 5

  • Disclaimer

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

  • Adverse Reactions

    100% Satisfaction

    Guaranteed!

    (888)309-9030

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

  • Principal display panel

    STUDIO

    SELECTION

    TEA TREE

    DANDRUFF SHAMPOO + CONDITIONER

    PYRITHIONE ZINC 1%

    Compare to Head & Shoulders® Tea Tree Oil 2 in 1 Dandruff Shampoo & Conditioner*

    Cooling relief from scalp itch

    Paraben free

    2in1

    Paraben + Phthalate Free

    12.5 FL OZ (370 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    PYRITHIONE ZINC 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75712-470
    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)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75712-470-32370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/25/2023
    Labeler - OLD EAST MAIN CO. (006946172)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(75712-470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(75712-470)
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