Label: HEAD REMEDY DANDRUFF CONDITIONER- pyrithione zinc emulsion

  • 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 August 19, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient: Zinc Pyrithione 1.0%

  • PURPOSE

    Purpose: Antidandruff

  • INDICATIONS & USAGE

    Use: Controls dandruff and flaking for a healthy scalp.

  • WARNINGS

    Warnings: For external use only.

  • ASK DOCTOR

    Ask a doctor before use if you have: seborrheic dermatitis that covers a large area of the body.

  • WHEN USING

    When using this product: do not get in eyes. If contact occurs, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if: condition worsens or does not improve after regular use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Children's Reach: If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Apply small amount on shampooed hair. Massage into wet hair and scalp. Leave in 2 minutes and rinse. For best results, use at least 2 times a week.

  • QUESTIONS

    Distributed by KPSS Inc., Linthicum Heights, MD 21090 USA, 1-800-342-5567

  • PRINCIPAL DISPLAY PANEL

    Image of 8.5 fl oz labelMM1: 8oz_dandruff_conditioner_label.jpg

  • INACTIVE INGREDIENT

    water, cetearyl alcohol, isopropyl palmitate, stearamidopropyl dimethylamine, phenethyl dimethicone, mineral oil, lactic acid, panthenol, butylene glycol, propylene glycol, glucose, Foeniculum vulgare (Fennel) fruit extract, Melissa officinalis (Balm) extract, Salvia officinalis (Sage) extract, Rosmarinus officinalis (Rosemary) extract, Urtica dioica (Nettle) extract, Equisetum arvense (Horsetail) extract, Humulus lupulus (Hops) extract, Chamomilla recutita (Matricaria) flower extract, caramel, sorbitol, sodium benzoate, potassium sorbate, DMDM Hydantoin, phenoxyethanol, tartaric acid, methylparaben, propylparaben, isobutylparaben, ethylparaben, butylparaben, fragrance, blue 1

  • INGREDIENTS AND APPEARANCE
    HEAD REMEDY DANDRUFF CONDITIONER 
    pyrithione zinc emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25237-0516
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.0 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25237-0516-1249.4 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/01/2006
    Labeler - KPSS, Inc. (808543149)
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