Label: EPOCH- 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 June 6, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Zinc Pyrithione 1%

  • Purpose

    Anti-dandruff

  • Use

    Controls the symptoms of dandruff.

  • Warning

    For external use only

    • Keep out of the 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 water.

    • If condition worsens or does not improve after regular use of the product as directed, consult a doctor.
  • Directions

    • Wet hair, lather thoroughly
    • Leave in 1–2 minutes and rinse well
    • For best results, use daily or at least twice a week (or as directed by a doctor).
  • Inactive Ingredients

    Water (Aqua), Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Acrylates/Aminoacrylates/C10-30 Alkyl PEG-20 Itaconate Copolymer, Cocamide MEA, Cocamide MIPA, Dimethicone, Zingiber Zerumbet Juice, Clematis Vitalba Leaf Extract, Mahonia Aquifolium Root Extract, Salvia Officinalis (Sage) Leaf Extract, Urtica Dioica (Nettle) Extract, Panthenol, Butylene Glycol, Sodium Chloride, Citric Acid, Tetrasodium EDTA, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Chlorophyllin-Copper Complex (CI 75810).

  • Questions?

    1-888-742-7626

  • PRINCIPAL DISPLAY PANEL - 250 ml Bottle Label

    epoch®

    Ava puhi moni®

    Anti-Dandruff
    Shampoo

    the "true ava puhi"

    250 ml e (8.4 fl. oz.)

    PRINCIPAL DISPLAY PANEL - 250 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    EPOCH   AVA PUHI MONI
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-2810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc10 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)  
    Coco Monoethanolamide (UNII: C80684146D)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Clematis Vitalba Leaf (UNII: 526T95850X)  
    Mahonia Aquifolium Root (UNII: 746TB9VNDP)  
    Sage (UNII: 065C5D077J)  
    Urtica Dioica (UNII: 710FLW4U46)  
    Panthenol (UNII: WV9CM0O67Z)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Sodium Copper Chlorophyllin (UNII: 1D276TYV9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-2810-1250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H10/01/2009
    Labeler - NSE Products, Inc. (966817975)
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