Active Ingredient
Pyrithione zinc 1%
Dandruff
FDA Label NDC 36800-309
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Dandruff (NDC 36800-309). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-dandruff
Uses
to help prevent recurrence of flaking and itching associated with dandruff.
Warnings
For external use only.
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 of this product as directed.
Keep Out Of Reach Of Children.
In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Directions
- for maximum dandruff control, use every time you shampoo.
- wet hair, massage onto scalp and rinse.
- repeat if desired.
Inactive Ingredients
Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Glycol Distearate, Zinc Carbonate, Sodium Xylenesulfonate, Cocamidopropyl Betaine, Dimethicone, Fragrance (Parfum), Sodium Benzoate, Guar Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Magnesium Sulfate, Benzyl Alcohol, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).
Label Copy
Image Of The Label (20237l)
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