Active Ingredient
Pyrithione zinc 1%
Zinc Pyrithione Shampoo
FDA Label NDC 70533-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Harry's Inc. for the product Zinc Pyrithione (NDC 70533-003). 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, otc - when using, otc - stop use, otc - 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
for relief and to help prevent recurrence of
flaking and itching associated with dandruff.
Warnings
For external use only.
Otc - When Using
When using this product avoid contact with 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 of this product as directed.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• for best results use at least twice a week or as
directed by a doctor.
• shake before use.
• wet hair, massage onto scalp, rinse, repeat if desired.
Inactive Ingredients
Water/Aqua/Eau, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Lauric Acid, Disodium Cocoamphodiacetate, Decyl Glucoside, Polysorbate 20, Sodium Chloride, Citric Acid, Acrylates Copolymer, Glycerin, Phenoxyethanol, Polyquaternium-6, Coconut Acid, Mentha Piperita (Peppermint) Oil, PEG-120 Methyl Glucose Dioleate, Polyquaternium-67, Coco-Glucoside, Glyceryl Oleate, Eucalyptus Globulus Leaf Oil, Guar Hydroxypropyltrimonium Chloride, Menthol, Butylene Glycol, Lavandula Hybrida Oil, Carica Papaya (Papaya) Fruit Extract, Chlorphenesin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Raphanus Sativus (Radish)
Root Extract, Potassium Hydroxide , Sodium Lauroyl Lactylate, Lavandula Angustifolia (Lavender) Oil, Sodium Caproyl Lactylate,
Propylene Glycol, Ferula Galbaniflua (Galbanum) Resin Oil, Sodium Polynaphthalenesulfonate, Sodium Acetate, Piper Nigrum (Pepper) Fruit Extract, Xanthan Gum, Isopropyl Alcohol, Benzoic Acid, Dehydroacetic Acid, Inga Alba Bark Extract, Tocopherol, Hydrogenated Palm Glycerides, Lecithin, Ascorbyl Palmitate, Linalool, Limonene.
Otc - Questions
Questions? 1-888-212-6855
* Please review the disclaimer below.
