Otc - Active Ingredient
Active Ingredient: Zinc Pyrithione 1.5%
Head Remedy
FDA Label NDC 25237-0515
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kpss Inc. for the product Head Remedy (NDC 25237-0515). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Antidandruff
Indications & Usage
Use: Controls dandruff and flaking for a healthy scalp.
Warnings
Warnings: For external use only.
Otc - Ask Doctor
Ask a doctor before use if you have: seborrheic dermatitis that covers a large area of the body.
Otc - When Using
When using this product: do not get in eyes. If contact occurs, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if: condition worsens or does not improve after regular use.
Otc - 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.
Otc - Questions
Distributed by KPSS Inc., Lithicum Heights, MD 21090 USA, 1-800-342-5567
Package Label.Principal Display Panel
Image Of 10.1 Fl Oz Label (10oz Dandruff Shampoo Label)
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
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