PYRITHIONE: 80 Adverse Event Reports & Safety Profile
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Active Ingredient: PYRITHIONE ZINC · Route: TOPICAL · Manufacturer: The Procter & Gamble Manufacturing Company · FDA Application: 019412 · HUMAN OTC DRUG · FDA Label: Available
First Report: 20141022 · Latest Report: 20240704
What Are the Most Common PYRITHIONE Side Effects?
All PYRITHIONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pruritus | 12 | 15.0% | 0 | 0 |
| Drug ineffective | 9 | 11.3% | 0 | 0 |
| Burning sensation | 6 | 7.5% | 0 | 0 |
| Rash | 6 | 7.5% | 0 | 0 |
| Eye irritation | 5 | 6.3% | 0 | 0 |
| Hair texture abnormal | 5 | 6.3% | 0 | 0 |
| Hypersensitivity | 5 | 6.3% | 0 | 1 |
Who Reports PYRITHIONE Side Effects? Age & Gender Data
Gender: 42.2% female, 57.8% male. Average age: 44.3 years. Most reports from: US. View detailed demographics →
Is PYRITHIONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 0 |
| 2015 | 3 | 0 | 0 |
| 2016 | 7 | 0 | 0 |
| 2017 | 4 | 0 | 0 |
| 2018 | 4 | 0 | 0 |
| 2019 | 3 | 0 | 0 |
| 2020 | 3 | 0 | 0 |
| 2021 | 4 | 0 | 0 |
| 2022 | 3 | 0 | 2 |
| 2023 | 6 | 0 | 0 |
| 2024 | 1 | 0 | 1 |
What Is PYRITHIONE Used For?
| Indication | Reports |
|---|---|
| Dandruff | 25 |
| Product used for unknown indication | 13 |
| Pruritus | 7 |
Official FDA Label for PYRITHIONE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Indication & Use - Jason Dandruff Relief Treatment 2-in-1 Shampoo & Conditioner Uses: Controls recurrance of flaking, scaling, and itching associated with dandruff Helps prevent seborrheic dermatitis
Dosage & Administration
Directions For best results, use at least twice a week, or as directed by a doctor. Shake well before use. Rub a liberal amount of product between palms and distribute throughout hair and scalp. Work product through hair & massage scalp with fingertips as you would a conventional shampoo. For easy detangling carefully comb through hair with a wide-tooth comb before rinsing co-wash from hair. Rinse and repeat if needed. Follow with conditioning.
Known Adverse Reactions
ADVERSE REACTION Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915. DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Head & Shoulders ®. Made in the USA with domestic and imported ingredients Factory Certified Empty & Discard Pump PLASTIC BOTTLE how2recylce.info
Warnings
Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Active Ingredient
Active ingredient Pyrithione zinc 1% (purifying shampoo) Pyrithione zinc 0.5% (moisturizing conditioner) Pyrithione zinc 0.1% (scalp soothing serum)
Inactive Ingredients
PURIFYING SHAMPOO Inactive ingredients water, sodium laureth sulfate, PEG-3 distearate, sodium laureth-8 sulfate, sodium chloride, cocamidopropyl betaine, sodium benzoate, acrylates/steareth-20 methacrylate copolymer, magnesium laureth sulfate, magnesium laureth-8 sulfate, sodium oleth sulfate, fragrance, mentha arvensis leaf oil, citric acid, magnesium oleth sulfate, polyquaternium-10, sodium hydroxide, propylene glycol, benzoic acid, mentha piperita oil, sodium polynaphthalenesulfonate, linalool, hexyl cinnamal, camellia sinensis leaf extract, limonene, geraniol, faex extract/yeast extract/extrait de levure, cellulose gum, biotin, lecithin, niacinamide, panthenol, tocopheryl acetate, ethoxydiglycol, methylisothiazolinone, methylparaben, glucose, propylparaben, lactic acid, achillea millefolium extract, betula alba leaf extract, equisetum arvense extract, rosmarinus officinalis (rosemary) leaf extract, salvia officinalis (sage) leaf extract, urtica dioica (nettle) extract, potassium sorbate.
Moisturizing Conditioner
Inactive ingredients water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, phenoxyethanol, dimethicone, glutamic acid, fragrance, mentha arvensis leaf oil, citric acid, propylene glycol, mentha piperita oil, linalool, hexyl cinnamal, camellia sinensis leaf extract, limonene, sodium polynaphthalenesulfonate, geraniol, faex extract/yeast extract/extrait de levure, cellulose gum, biotin, lecithin, niacinamide, panthenol, tocopheryl acetate, ethoxydiglycol, methylisothiazolinone, methylparaben, glucose, propylparaben, lactic acid, sodium benzoate, achillea millefolium extract, betula alba leaf extract, equisetum arvense extract, rosmarinus officinalis (rosemary) leaf extract, salvia officinalis (sage) leaf extract, urtica dioica (nettle) extract, potassium sorbate, calcium pantothenate, inositol, tartaric acid, caramel.
Scalp Soothing Serum
Inactive ingredients water, phenoxyethanol, cetyl alcohol, stearamidopropyl dimethylamine, stearyl alcohol, hydroxyethylcellulose, distearyldimonium chloride, PEG-2M, dimethicone, fragrance, cetearyl alcohol, mentha arvensis leaf oil, glyceryl stearate, oleyl alcohol, citric acid, polysorbate 60, propylene glycol, mentha piperita oil, camellia sinensis leaf extract, linalool, hexyl cinnamal, hexamethylindanopyran, limonene, silica, geraniol, faex extract/yeast extract/extrait de levure, tetramethyl acetyloctahydronaphthalenes, benzyl salicylate, sodium polynaphthalenesulfonate, alpha-isomethyl ionone, disodium phosphate, biotin, lecithin, niacinamide, panthenol, tocopheryl acetate, citrus aurantium peel oil, linalyl acetate, citrus limon peel oil, trimethylbenzenepropanol, ethoxydiglycol, cellulose gum, sodium phosphate, BHT, methylparaben, glucose, propylparaben, methylisothiazolinone, lactic acid, sodium benzoate, achillea millefolium extract, betula alba leaf extract, equisetum arvense extract, rosmarinus officinalis (rosemary) leaf extract, salvia officinalis (sage) leaf extract, urtica dioica (nettle) extract, potassium sorbate, calcium pantothenate, inositol, tartaric acid, caramel.