Restoring Serum (73528-400)

Restoring Serum (73528-400)
SPL v8
SPL
SPL Set ID 984816e3-3096-44c6-e053-2995a90af1aa
Route
TOPICAL
Published
Effective Date 2022-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (0.125 g)
Inactive Ingredients
Water Potassium Sorbate Sodium Mono- And Dimethyl Naphthalene Sulfonates Sodium Chloride Caprylic/capric Triglyceride Punica Granatum Fruit Juice Epilobium Angustifolium Whole Dipropylene Glycol Citrus Limon (lemon) Peel Oil Propylene Glycol Hexyl Cinnamal Salicylic Acid Xanthan Gum Panthenol Camphor (natural) Raphanus Sativus Var. Caudatus Root 1,2-hexanediol Propanediol Menthol Sodium Benzoate Pea Protein Citric Acid Caprylyl Glycol Lavandula Angustifolia (lavender) Oil Linalool Mentha Piperita (peppermint) Oil Lavandin Oil Terpineol Potassium Hydroxide Geranyl Acetate Aloe Barbadensis Leaf Juice Gluconolactone Sodium Polyacryloyldimethyl Taurate Niacinamide Butylene Glycol Pisum Sativum Whole Yeast, Unspecified Rosmarinus Officinalis (rosemary) Leaf Oil Leuconostoc/radish Root Ferment Filtrate Linalyl Acetate Vanillin Illicium Verum Whole Pentadecalactone 3-octanone Salvia Officinalis (sage) Oil 3-hexenol Pinene Glycerin Geraniol Limonene, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-01
Description

Zinc Pyrithione 0.125%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For the relief of symptoms from scalp itch, irritation, flaking and redness associated with dandruff.

Dosage and Administration
  • Apply a thin layer across the scalp (dry or damp). Gently massage into the scalp and leave-on.
  • Repeat if desired up to four times a day.
  • For best results, use at least twice a week or as directed by a doctor.
Description

Zinc Pyrithione 0.125%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Section 50567-7

Avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Section 51727-6

Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Propanediol, Glycerin, Gluconolactone, Sodium Polyacryloyldimethyl Taurate, Niacinamide, Salicylic Acid, Butylene Glycol, Sodium Benzoate, Xanthan Gum, Caprylic/Capric Triglyceride, Panthenol, Potassium Hydroxide, Pisum Sativum (Pea) Peptide, Punica Granatum Extract, Yeast Ferment Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Cetearamidoethyl Diethonium Succinoyl Hydrolyzed Pea Protein, Rosmarinus Officinalis (Rosemary) Leaf Extract, Propylene Glycol, Citric Acid, Potassium Sorbate, Raphanus Sativus (Radish) Leaf Extract, Leuconostoc/Radish Root Ferment Filtrate, 1,2-Hexanediol, Caprylyl Glycol, Sodium Polynaphthalenesulfonate, Sodium Chloride, Camphor, Citrus Limon (Lemon) Peel Oil, Geranyl Acetate, Lavandula Oil/Extract, Limonene, Linalyl Acetate, Linalool, Mentha Piperitta (Peppermint) Oil, Menthol, Terpineol, Vanillin, Lavandin Abrialis Oil, Illicium Verum (Anise) Fruit/Seed Oil, Dipropylene Glycol, Pentadecalactone, Geraniol, Hexyl Acetate, Ethyl Amyl Ketone, Salvia Officinalis (Sage) Oil, 3-Hexenol, Pinene.

Section 51945-4

Section 53413-1

1-877-No-Flake (1-877-663-5253)

Section 55105-1

Anti-Dandruff, Anti-seborrheic dermatitis

Section 55106-9

Zinc Pyrithione 0.125%

Structured Label Content

Indications and Usage (34067-9)

For the relief of symptoms from scalp itch, irritation, flaking and redness associated with dandruff.

Dosage and Administration (34068-7)
  • Apply a thin layer across the scalp (dry or damp). Gently massage into the scalp and leave-on.
  • Repeat if desired up to four times a day.
  • For best results, use at least twice a week or as directed by a doctor.
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Section 50567-7 (50567-7)

Avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Section 51727-6 (51727-6)

Aqua (Water, Eau), Aloe Barbadensis Leaf Juice, Propanediol, Glycerin, Gluconolactone, Sodium Polyacryloyldimethyl Taurate, Niacinamide, Salicylic Acid, Butylene Glycol, Sodium Benzoate, Xanthan Gum, Caprylic/Capric Triglyceride, Panthenol, Potassium Hydroxide, Pisum Sativum (Pea) Peptide, Punica Granatum Extract, Yeast Ferment Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Cetearamidoethyl Diethonium Succinoyl Hydrolyzed Pea Protein, Rosmarinus Officinalis (Rosemary) Leaf Extract, Propylene Glycol, Citric Acid, Potassium Sorbate, Raphanus Sativus (Radish) Leaf Extract, Leuconostoc/Radish Root Ferment Filtrate, 1,2-Hexanediol, Caprylyl Glycol, Sodium Polynaphthalenesulfonate, Sodium Chloride, Camphor, Citrus Limon (Lemon) Peel Oil, Geranyl Acetate, Lavandula Oil/Extract, Limonene, Linalyl Acetate, Linalool, Mentha Piperitta (Peppermint) Oil, Menthol, Terpineol, Vanillin, Lavandin Abrialis Oil, Illicium Verum (Anise) Fruit/Seed Oil, Dipropylene Glycol, Pentadecalactone, Geraniol, Hexyl Acetate, Ethyl Amyl Ketone, Salvia Officinalis (Sage) Oil, 3-Hexenol, Pinene.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-877-No-Flake (1-877-663-5253)

Section 55105-1 (55105-1)

Anti-Dandruff, Anti-seborrheic dermatitis

Section 55106-9 (55106-9)

Zinc Pyrithione 0.125%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:25.766637 · Updated: 2026-03-14T23:13:03.799451