Otc - Active Ingredient
Zinc Pyrithione 0.125%
Treatment Cream
FDA Label NDC 73528-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zero Flakes Given, Inc. for the product Treatment (NDC 73528-400). 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, warnings, indications & usage, dosage & administration, otc - questions, inactive ingredient, 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
Anti-Dandruff
Warnings
For external use only.
Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
If condition worsens or does not improve after regular use of this product as directed, consult a doctor.
Keep out of reach of children. If swallowed, call a poinson control center or get medical help right away.
Do not use on children under 2 years of age, unless directed by a doctor.
Indications & Usage
For the relief of symptoms from scalp itch, irritation, flaking and redness associated with dandruff.
Dosage & Administration
Apply to affected areas 1 to 4 times daily or as directed by a doctor.
Apply liberally tyo damp or dry scalp, and gently massage with fingertips.
Do not rinse off.
Otc - Questions
1-877-No-Flake (1-877-663-5253)
Inactive Ingredient
Water (Aqua), Aloe Barbadensis (Aloe Vera) Leaf Juice, Propanediol, Glycerin, Carthamus Tinctorius (Safflower) Seed Oil, Mentha Aquatica Leaf Oil, Mentha Arvensis (Cornmint) Leaf Oil, Salicylic Acid, Camellia Sinensis Leaf Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Niacinamide, Panthenol, Lavandula Angustifolia (Lavender) Oil, Allium Sativum (Garlic) Bulb Extract, Yeast Ferment Extract, Cocos Nucifera (Coconut) Oil, Citrus Reticulata (Tangerine) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Salvia Sclarea (Clary) Oil, Vanillin, Cetearamidoethyldiethonium Succinoyl Hydrolyzed Pea Protein, Lactobacillus Ferment, Xanthan Gum, Sodium Polyacryloyldimethyl Taurate, Silica, Sodium Hydroxide, Sodium Polynaphthalenesulfonate
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE REACH OF CHILDREN.
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