Label: MEDACLEAR- zinc pyrithione 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 December 29, 2011

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  • Active ingredient

     Zinc Pyrithione 1.5%

  • Purpose

     Antidandruff and Antisebborrheic Dermatitis

  • Use

     helps prevent the symptoms from dandruff and/or Seborrheic Dermatitus such as itching, flaking, irritation and redness.

  • Warnings

    For external use only

    Ask a doctor before use

     if you have seborrheic dermatitis that covers a large area of the body.

    On children under 2 years of age.

    When using this product

     avoid contact with 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.

    Keep out of reach of children

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

  • Directions

    Wet hair, massage into scalp, rinse, repeat if desired.  For maximum dandruff control, use every time you shampoo.  For best results, use twice a week, or as directed by a doctor.

  • Other information

     Shampoo Scalp & Skin Treatment

    Medicated Formula

    Treatment for:

    • Flaking Scalp & Skin
    • Oily Scalp
    • Itchy Scalp

    Symptom Relief for:

    • Seborrheic Dermatitus and Psoriasis
  • Inactive ingredients

     Citric Acid, Cocamide DEA, DMDM Hydantoin, Dyes, Ethylene Glycol Monostearate, Fragrance, Purified Water, Sodium Chloride, TEA Lauryl Sulfate

  • Questions?

     1-800-JohnAmico

  • Principal Display Panel

     8oz label:

    8oz Label

    8oz Label

  • Distributed By

     John Amico Haircare Products

    4731 W. 136th Street, Crestwood, IL 60445

    www.johnamico.com

  • INGREDIENTS AND APPEARANCE
    MEDACLEAR 
    zinc pyrithione shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51290-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC15.0 g  in 1.0 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51290-011-080.24 L in 1 BOTTLE
    2NDC:51290-011-320.95 L in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H09/08/2010
    Labeler - Amico Educational Concepts, Inc. (127642333)
    Registrant - Continental Manufacturing Chemist, Inc. (005278007)
    Establishment
    NameAddressID/FEIBusiness Operations
    Continental Manufacturing Chemist, Inc.005278007MANUFACTURE(51290-011)
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