Home SPL Set DailyMed Nioxin Pro Clinical Scalp Recovery System For Anti-dandruff Nioxin Pro Clinical Scalp Recovery System For Anti-dandruff SPL v3 SPL SPL Set ID 31bf4f7f-8228-7433-e063-6394a90a2f5f Route TOPICAL Published Effective Date 2025-04-01 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Pyrithione Zinc (0.5 g) Inactive Ingredients Inositol Cellulose Gum Dimethicone Niacinamide Methylisothiazolinone Citric Acid Formaldehyde/sodium Naphthalenesulfonate Copolymer (3000 Mw) Hexyl Cinnamal Geraniol Urtica Dioica Leaf Water Mentha Arvensis Leaf Oil Lecithin, Soybean Ethoxydiglycol Lactic Acid Phenoxyethanol Sodium Benzoate Equisetum Arvense Branch Caramel Achillea Millefolium Yeast, Unspecified Panthenol Glucose Mentha Piperita (peppermint) Oil Propylene Glycol Sage Stearyl Alcohol Potassium Sorbate Hexamethylindanopyran Biotin Cetyl Alcohol Stearamidopropyl Dimethylamine Glutamic Acid .alpha.-tocopherol Acetate, D- Limonene, (+/-)- Rosemary Betula Alba Leaf Tartaric Acid Calcium Pantothenate Methylparaben Propylparaben Linalool, (+/-)- Camellia Sinensis Leaf Sodium Chloride Sodium Laureth Sulfate Peg-3 Distearate Sodium Laureth-8 Sulfate Benzoic Acid Polyquaternium-10 (400 Mpa.s At 2%) Magnesium Laureth Sulfate Acrylates/steareth-20 Methacrylate Copolymer Sodium Hydroxide Sodium Oleth Sulfate Magnesium Laureth-8 Sulfate Magnesium Oleth Sulfate Cocamidopropyl Betaine Cetearyl Alcohol Tetramethyl Acetyloctahydronaphthalenes Linalyl Acetate Oleyl Alcohol Glyceryl Stearate Peg-2m Sodium Phosphate Hydroxyethylcellulose Citrus Aurantium Peel Oil Citrus Limon (lemon) Peel Oil Silica Distearyldimonium Chloride Disodium Phosphate Polysorbate 60 Trimethylbenzenepropanol Bht Benzyl Salicylate Alpha-isomethyl Ionone Identifiers & Packaging Marketing Status OTC MONOGRAPH DRUG Active Since 2025-04-01 Description Drug Facts Medication Information Warnings and Precautions Warnings For external use only. Indications and Usage Uses Helps prevent recurrence of flaking and itching associated with dandruff. Dosage and Administration Directions PURIFYING SHAMPOO For best results use at least twice a week or as directed by a doctor. Massage on to wet scalp and hair. Rinse. Repeat if desired. MOISTURIZING CONDITIONER For best results use at least twice a week or as directed by a doctor. Apply to wet scalp and hair, leave for 1-3 minutes. Rinse well. SCALP SOOTHING SERUM Apply to affected areas one to four times daily or as directed by a doctor. Description Drug Facts Section 42229-5 Drug Facts 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 When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Section 51727-6 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. Section 51945-4 nioxin® PRO CLINICAL SCALP RECOVERY™ SYSTEM FOR ANTI-DANDRUFF FOR ITCHY, FLAKY SCALP WITH PYRITHIONE ZINC FOR ALL HAIR TYPES CLINICALLY & DERMATOLOGICALLY TESTED SCALP RECOVERY™ purifying shampoo SCALP RECOVERY™ moisturizing conditioner SCALP RECOVERY™ scalp soothing serum 200 mL | 6.7 FL OZ 200 mL | 6.7 FL OZ 100 mL | 3.3 FL OZ Section 53413-1 Questions? 1-800-935-5273 Section 55105-1 Purpose Anti-dandruff Section 55106-9 Active ingredient Pyrithione zinc 1% (purifying shampoo) Pyrithione zinc 0.5% (moisturizing conditioner) Pyrithione zinc 0.1% (scalp soothing serum) Structured Label Content Indications and Usage (34067-9) Uses Helps prevent recurrence of flaking and itching associated with dandruff. Dosage and Administration (34068-7) Directions PURIFYING SHAMPOO For best results use at least twice a week or as directed by a doctor. Massage on to wet scalp and hair. Rinse. Repeat if desired. MOISTURIZING CONDITIONER For best results use at least twice a week or as directed by a doctor. Apply to wet scalp and hair, leave for 1-3 minutes. Rinse well. SCALP SOOTHING SERUM Apply to affected areas one to four times daily or as directed by a doctor. Warnings and Precautions (34071-1) Warnings For external use only. Section 42229-5 (42229-5) Drug Facts 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) When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Section 51727-6 (51727-6) 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. Section 51945-4 (51945-4) nioxin® PRO CLINICAL SCALP RECOVERY™ SYSTEM FOR ANTI-DANDRUFF FOR ITCHY, FLAKY SCALP WITH PYRITHIONE ZINC FOR ALL HAIR TYPES CLINICALLY & DERMATOLOGICALLY TESTED SCALP RECOVERY™ purifying shampoo SCALP RECOVERY™ moisturizing conditioner SCALP RECOVERY™ scalp soothing serum 200 mL | 6.7 FL OZ 200 mL | 6.7 FL OZ 100 mL | 3.3 FL OZ Section 53413-1 (53413-1) Questions? 1-800-935-5273 Section 55105-1 (55105-1) Purpose Anti-dandruff Section 55106-9 (55106-9) Active ingredient Pyrithione zinc 1% (purifying shampoo) Pyrithione zinc 0.5% (moisturizing conditioner) Pyrithione zinc 0.1% (scalp soothing serum) Advanced Ingredient Data [{"name": "INOSITOL", "unii": "4L6452S749", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE GUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", 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with dandruff.", "34068-7": "Directions PURIFYING SHAMPOO For best results use at least twice a week or as directed by a doctor. Massage on to wet scalp and hair. Rinse. Repeat if desired. MOISTURIZING CONDITIONER For best results use at least twice a week or as directed by a doctor. Apply to wet scalp and hair, leave for 1-3 minutes. Rinse well. SCALP SOOTHING SERUM Apply to affected areas one to four times daily or as directed by a doctor.", "34071-1": "Warnings For external use only.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if Condition worsens or does not improve after regular use of this product as directed.", "50567-7": "When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.", "51727-6": "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.", "51945-4": "nioxin® PRO CLINICAL SCALP RECOVERY™ SYSTEM FOR ANTI-DANDRUFF FOR ITCHY, FLAKY SCALP WITH PYRITHIONE ZINC FOR ALL HAIR TYPES CLINICALLY & DERMATOLOGICALLY TESTED SCALP RECOVERY™ purifying shampoo SCALP RECOVERY™ moisturizing conditioner SCALP RECOVERY™ scalp soothing serum 200 mL | 6.7 FL OZ 200 mL | 6.7 FL OZ 100 mL | 3.3 FL OZ", "53413-1": "Questions? 1-800-935-5273", "55105-1": "Purpose Anti-dandruff", "55106-9": "Active ingredient Pyrithione zinc 1% (purifying shampoo) Pyrithione zinc 0.5% (moisturizing conditioner) Pyrithione zinc 0.1% (scalp soothing serum)"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T12:07:20.503382 · Updated: 2026-03-14T23:10:41.056891