Label: HEAD REMEDY- 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 August 19, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient: Zinc Pyrithione 1.5%

  • 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: Work shampoo into palms and massage into wet hair and scalp. Rinse and repeat if necessary. For best results, use at least 2 times a week.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Image of 10.1 fl oz label
    MM1 : 10oz_dandruff_shampoo_label.jpg

  • INACTIVE INGREDIENT

    water, sodium laureth sulfate, cocamidopropyl betaine, acrylates copolymer, sodium cocyl glutamate, PEG-3 distearate, hydroxypropyl guar hydroxypropyltrimonium chloride, panthenol, Foeniculum vulgare (Fennel) fruit extract, Malissa 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) extract, PPG-9, lactic acid, citric acid, propylene glycol, quaternium-80, butylene glycol, glucose, sorbitol, sodium hydroxide, sodium chloride, sodium benzoate, DMDM Hydantoin, fragrance, Blue 1

  • INGREDIENTS AND APPEARANCE
    HEAD REMEDY 
    zinc pyrithione shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25237-0515
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc1.5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25237-0515-2310.3 g in 1 BOTTLE, DISPENSING
    2NDC:25237-0515-1777.4 g in 1 BOTTLE, PUMP
    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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