Active Ingredient
Pyrithione zinc 2% w/w
Dandrene
FDA Label NDC 72249-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Divine Skin Laboratories S.a. De C.v. for the product Dandrene (NDC 72249-100). 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 - stop use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-dandruff
Uses
Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff.
Warnings
For external use only.
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 Poison Control Center right away.
Directions
Apply shampoo to wet hair and scalp with a gentle massage, leave in for 2-3 minutes, rinse.
For best results use at least 2 times per week or as directed by a doctor.
For maximum benefit use 4-5 times a week along with Dandrene Anti-Dandruff Conditioner.
Inactive Ingredients
Water, Sodium Lauryl Sulfoacetate, Disodium Laureth Sulfosuccinate, Sodium Lauroyl Sarcosinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Glyceryl Stearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Pomegranage Peel (Punica Granutum) Extract, Rosemary (Rosmarinus Officinalis) Leaf Extract, Shikimic Acid, Tioxolone, Emu Oil, Fragrance, Blue 1
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