Active Ingredient
Zinc Pyrithione 1%
Paul Mitchell Dandruff Shampoo
FDA Label NDC 75593-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by John Paul Mitchell Systems for the product Paul Mitchell Dandruff (NDC 75593-001). 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, when using this product, stop use and ask a doctor if, keep out of reach of children., directionsdirections, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-dandruff
Uses
Controls recurrence of scalp flaking, itching, and scaling associated with dandruff.
Warnings
For external use only.
When Using This Product
• Avoid contact with eyes.
• In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use And Ask A Doctor If
• Irritation or rash occurs.
• Condition worsens or does not improve after regular use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
If swallowed, get medical help or contact a Poison Control Center right away.
Directionsdirections
• Apply to damp hair.
• Massage onto scalp, then rinse.
• For best results, use at least twice a week or as directed by a doctor.
• For maximum dandruff control, use every time you shampoo.
Inactive Ingredientsinactive Ingredients
Water (Aqua, Eau), Sodium C14-16 Olefin Sulfonate, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Pyrus Malus (Apple) Fruit Extract, Hydrogenated Palm Glycerides Citrate, Sodium Chloride, Glycerin, Glyceryl Oleate, Coco-Glucoside, Glycol Distearate, Bis-Diisopropanolamino-PG-propyl Dimethicone/Bis-Isobutyl PEG-14 Copolymer, PEG-150 Distearate, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Citric Acid, Propylene Glycol, Polysorbate 20, Butyloctanol, Magesium Nitrate, Lactic Acid, Tetrasodium EDTA, Sodium Polynaphthalenesulfonate, Xanthan Gum, Magnesium Chloride, Tocopherol, Sodium Benzoate, Phenoxyethanol, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance (Parfum), Benzyl Benzoate, Hexyl Cinnamal, Amyl Cinnamal, Linalyl Acetate, Limonene, Linalool
Questions Or Comments:
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