Label: THERAPEUTIC - pyrithione zinc rinse

  • NDC Code(s): 59279-514-06, 59279-514-12, 59279-514-33
  • Packager: Mediceutical Laboratories, LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

If you are a consumer or patient please visit this version.

  • Active ingredient

    Pyrithione Zinc 0.5%

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  • Purpose

    anti-dandruff, anti-seborrheic, dermatitis

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  • Uses

    • Helps prevent recurrence of flaking and itching associated with dandruff and seborrheic dermatitis
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  • 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.

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

    If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with cool water.

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  • 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 TherapeuticTM 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.
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  • Inactive ingredients

    Ascorbic Acid (Vitamin C), Behentrimonium Methosulfate, Blue 1 (CL 42090), Capryly Glycol, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Extract, Ethylhexly Methoxycinnamate, Fragrance (Parfum), Gingko Biloba Root Extract, Guar Hydroxypropyltrimonium Chloride, Hamamelis Virginiana (Witch Hazel) Extract, Hexylene Glycol, Humulus Lupulus (Hops) Extract, Hydrastis Canadensis (Golden Seal) Extract, Menthol, Phenoxyethanol, Rosmarinius Officinalis (Rosemary) Extract, Tetrasodium EDTA, Wate (Aqua)

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  • Package Label-Principal Display Panel

    THERAPEUTICTM

    SCALP AND HAIR TREATMENT RINSE

    MEDICEUTICALS®

    Cruelty Free. Not tested on Animals.

    Sold exclusively through fine Salons, Spas and Hair Restoration Clinics

    Manufactured in the USA for:

    Mediceutical Laboratories, LTD Fort Worth, Texas 76118

    Customer Service: 1-800-433-2903

    Mediceutical Europe B.V.

    Kelvinstraat 61, 2723 RJ Zoetermmer The Netherlands EU

    Telephone: +31 79 3314029

    NDC 5927951433 THERAPEUTICTM 33.8 fl oz

    NDC 5927951406 THERAPEUTICTM 6 fl oz

    NDC 5927951412 THERAPEUTICTM 12 fl oz

    Front

    TherapeuticFront

    Back

    TherapeuticBack


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  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC 
    pyrithione zinc rinse
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59279-514
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ASCORBIC ACID  
    FD&C BLUE NO. 1  
    CAPRYLYL GLYCOL  
    CETOSTEARYL ALCOHOL  
    MATRICARIA RECUTITA  
    OCTINOXATE  
    GINKGO  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK  
    HEXYLENE GLYCOL  
    HOPS  
    GOLDENSEAL  
    MENTHOL  
    PHENOXYETHANOL  
    ROSEMARY  
    EDETATE SODIUM  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59279-514-33 1000 mL in 1 BOTTLE, PLASTIC
    2 NDC:59279-514-12 360 mL in 1 BOTTLE, PLASTIC
    3 NDC:59279-514-06 180 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 01/01/2007
    Labeler - Mediceutical Laboratories, LTD (136770067)
    Registrant - Mediceutical Laboratories, LTD (136770067)
    Establishment
    Name Address ID/FEI Business Operations
    United 1 International Laboratories 807878116 manufacture(59279-514)
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