Active Ingredient
Pyrithione zinc 0.3%
Dandruff Shampoo
FDA Label NDC 80801-103
9 label sections · Submitted to the FDA by Primal Elements · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Primal Elements for the product Dandruff (NDC 80801-103). 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, use, warnings, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-dandruff
Use
helps prevent recurrence of flaking and itching associated with dandruff.
Warnings
For external use only.
When using this product do not get into 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 as directed.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Posion Control Center right away.
Directions
• shake well • for maximum dandruff control, use every time you shampoo • wet hair, massage onto scalp, rinse, repeat if desired • for best results, use at least twice a week or as directed by a doctor
Other Information
Store at room temperature.
Inactive Ingredients
Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Cocamide MEA, Styrene/Acrylates Copolymer, Guar Hydroxypropyltrimonium Chloride, Sodium Citrate, Fragrance, Sodium Chloride, Dimethicone, Methylisothiazolinone, Iodopropynyl Butylcarbamate
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