Active Ingredients
Zinc Pyrithione 2%
Zinc Pyrithione Shampoo
FDA Label NDC 70533-004
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 70533-004). 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 ingredients, purpose, uses, warnings, otc - ask doctor, otc - when using, otc - stop use, 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
Purpose
Anti-dandruff,
Anti-seborrheic dermatitis
Uses
for relief and to help prevent recurrence of flaking and itching associated with dandruff and seborrheic dermatitis.
Warnings
For external use only.
Otc - Ask Doctor
Ask a doctor before use if you have a condition that covers a large area of the body.
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, Acrylates Copolymer, Citric Acid, Glycerin, Phenoxyethanol, Polyquaternium-39,
Polyquaternium-6, Coconut Acid, Mentha Piperita (Peppermint) Oil, PEG-120 Methyl Glucose Dioleate, Polyquaternium-67, Coco-Glucoside, Glyceryl Oleate, Eucalyptus Globulus Leaf Oil, Propanediol, Menthol, Raphanus Sativus (Radish) Root Extract, Lavandula
Hybrida Oil, Propylene Glycol, Carica Papaya (Papaya) Fruit Extract, Chlorphenesin, Potassium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Ziziphus Joazeiro Bark Extract, Sodium Polynaphthalenesulfonate, Ferula Galbaniflua (Galbanum) Resin Oil, Xanthan Gum, Sodium Acetate, Butylene Glycol, Sodium Benzoate, Isopropyl Alcohol, Tocopherol, Hydrogenated Palm Glycerides, Lecithin, Ascorbyl Palmitate, Linalool, Limonene.
Otc - Questions
Questions? 1-888-212-6855
* Please review the disclaimer below.
