Otc - Active Ingredient
Active Ingredient Purpose
Zinc Pyrithione 1% Anti-dandruff
Basic Essentials Dandruff
FDA Label NDC 50438-607
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Filo America for the product Basic Essentials Dandruff (NDC 50438-607). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Helps prevent recurrence of flaking and itching associated with dandruff.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Do not get into eyes, if contact occurs, rinse eyes thoroughly with water.
Indications & Usage
Shake well, wet hair, massage onto scalp. Rinse, repeat if desired.
For best results, use at least twice a week or as directed by a doctor.
For maximum dandruff control, use every time you shampoo.
Warnings
For external use only.
Stop use and ask a doctor if Condition worsens or does not improve after regular use as directed.
Dosage & Administration
apply as needed.
Inactive Ingredient
water, sodium laureth sulfate, cocamidopropyl betaine, sodium lauroamphoacetate, glycol stearate, acrylates/acrylamide copolymer, ammonium chloride, methylchloroisothiazolinone, methylisothiazolinone, fragrance, citric acid, guar hydroxypropyltrimonium chloride, titanium dioxide, disodium EDTA, zinc chloride, blue 1, red 4
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