HEAD REMEDY - zinc pyrithione shampoo 
KPSS Inc.

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.

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Drug Facts

Active Ingredient: Zinc Pyrithione 1.5%

Purpose: Antidandruff

Use: Controls dandruff and flaking for a healthy scalp.

Warnings: For external use only.

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

When using this product: do not get in 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 children's reach. If swallowed, get medical help or contact a Poison Control Center right away.

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.

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

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

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

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)

Revised: 8/2010
Document Id: f41ee57f-b8d5-4801-b8aa-11da4f07d304
Set id: a7cba417-cbb4-4345-80ba-21a004d5da0e
Version: 3
Effective Time: 20100819
 
KPSS Inc.