Label: THERAPEUTIC- zinc pyrithione rinse

  • 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 13, 2022

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  • Active ingredient

    Pyrithione Zinc 1%

  • Purpose

    anti-dandruff, anti-seborrheic, dermatitis

  • Uses

    HELPS CONTROL AND PREVENT FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITUS.

  • Warnings

    For external use only. If condition worsens or does not improve after regular use of this product as directed, discontinue and consult a physician. If condition covers a large area of the body, consult your physician before using this product.

    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with cool water.

  • Keep this and all drugs out of reach of children.

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

  • Directions

    For best results use daily or until conditionis iunder control or as directed by a physician.  For maximum control use every time you shampoo.

    1. Cleanse with appropriate Mediceuticals® shampoo
    2. Work ample amount of Therapeutic TM Scalp and Hair Treatment Rinse evenly through hair, gently massage onto the scalp, leave on 1-2 minutes
    3. Thoroughly rinse

    Consult your Salon professional for additional Mediceuticals® scalp and hair treatment specifically tailored for your condition.

  • Inactive ingredients

    WATER (AQUA), BEHENTRIMONIUM METHOSULFATE, CETEARYL ALCOHOL, CETYL ALCOHOL, PHENOXYETHANOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HUMULUS LUPULUS (HOPS) EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, HYDRASTIS CANADENSIS (GOLDENSEAL) EXTRACT, HAMAMELIS VIRGINIANA (WITCH hAZEL) LEAF EXTRACT, ASCORBIC ACID, ETHYLHEXYL METHOXYCINNAMATE, TETRASODIUM EDTA, MENTHOL, GINKGO BILOBA, FRAGRANCE (PARFUM), BLUE 1 (CI 42090).

  • PRINCIPAL DISPLAY PANEL

    Therapeutic 250ml_FrontTherapeutic 250ml_Back

  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC 
    zinc pyrithione rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59279-515
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    HOPS (UNII: 01G73H6H83)  
    ROSEMARY (UNII: IJ67X351P9)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    MENTHOL (UNII: L7T10EIP3A)  
    GINKGO BILOBA WHOLE (UNII: 660486U6OI)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59279-515-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2020
    2NDC:59279-515-12250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/01/2007
    Labeler - Mediceutical Laboratories, LTD (080520685)