NIOXIN PRO CLINICAL SCALP RECOVERY- pyrithione zinc kit
nioxin PRO CLINICAL SCALP RECOVERY by
Drug Labeling and Warnings
nioxin PRO CLINICAL SCALP RECOVERY by is a Otc medication manufactured, distributed, or labeled by Wella Operations US LLC, kdc/one Chatsworth, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & 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.
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INACTIVE INGREDIENT
PURIFYING SHAMPOO
Inactive ingredients water, sodium laureth sulfate, PEG-3 distearate, sodium laureth-8 sulfate, sodium chloride, cocamidopropyl betaine, acrylates/steareth-20 methacrylate copolymer, magnesium laureth-8 sulfate, magnesium laureth sulfate, sodium oleth sulfate, fragrance, sodium benzoate, citric acid, DMDM hydantoin, mentha arvensis leaf oil, mentha piperita (peppermint) oil, magnesium oleth sulfate, sodium hydroxide, polyquaternium-10, propylene glycol, benzoic acid, linalool, hexyl cinnamal, camellia sinensis leaf extract, sodium polynaphthalenesulfonate, benzyl alcohol, limonene, geraniol, cellulose gum, yeast extract, niacinamide, tocopheryl acetate, panthenol, biotin, lecithin, ethoxydiglycol, maltodextrin, methylparaben, glucose, propylparaben, lactic acid, achillea millefolium extract, betula alba leaf extract, urtica dioica (nettle) extract, salvia officinalis (sage) leaf extract, rosmarinus officinalis (rosemary) leaf extract, equisetum arvense extract, potassium sorbate, calcium pantothenate, inositol, tartaric acid, caramel.
MOISTURIZING CONDITIONER
Inactive ingredients water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, dimethicone, glutamic acid, benzyl alcohol, phenoxyethanol, fragrance, methylparaben, mentha arvensis leaf oil, mentha piperita (peppermint) oil, citric acid, propylene glycol, linalool, hexyl cinnamal, camellia sinensis leaf extract, limonene, sodium polynaphthalenesulfonate, geraniol, DMDM hydantoin, cellulose gum, yeast extract, niacinamide, panthenol, biotin, lecithin, tocopheryl acetate, ethoxydiglycol, maltodextrin, glucose, propylparaben, lactic acid, sodium benzoate, equisetum arvense extract, rosmarinus officinalis (rosemary) leaf extract, salvia officinalis (sage) leaf extract, urtica dioica (nettle) extract, achillea millefolium extract, betula alba leaf extract, potassium sorbate, inositol, calcium pantothenate, tartaric acid, caramel.
SCALP SOOTHING SERUM
Inactive ingredients water, cetyl alcohol, stearamidopropyl dimethylamine, stearyl alcohol, distearyldimonium chloride, hydroxyethylcellulose, benzyl alcohol, phenoxyethanol, PEG-2M, dimethicone, fragrance, cetearyl alcohol, methylparaben, glyceryl stearate, oleyl alcohol, mentha arvensis leaf oil, mentha piperita (peppermint) oil, citric acid, polysorbate 60, propylene glycol, camellia sinensis leaf extract, linalool, hexyl cinnamal, limonene, silica, geraniol, benzyl salicylate, alpha-isomethyl ionone, sodium polynaphthalenesulfonate, yeast extract, disodium phosphate, niacinamide, panthenol, biotin, lecithin, tocopheryl acetate, ethoxydiglycol, DMDM hydantoin, maltodextrin, cellulose gum, sodium phosphate, BHT, glucose, propylparaben, lactic acid, sodium benzoate, betula alba leaf extract, achillea millefolium extract, utica dioica (nettle) extract, salvia officinalis (sage) leaf extract, rosmarinus officinalis (rosemary) leaf extract, equisetum arvense extract, potassium sorbate, calcium pantothenate, inositol, caramel, tartaric acid
- QUESTIONS
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
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) 
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INGREDIENTS AND APPEARANCE
NIOXIN PRO CLINICAL SCALP RECOVERY
pyrithione zinc kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 82157-010 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 82157-010-99 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 12/19/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 200 mL Part 2 1 BOTTLE, PLASTIC 100 mL Part 3 1 BOTTLE, PLASTIC 200 mL Part 1 of 3 NIOXIN PRO CLINICAL SCALP RECOVERY MOISTURIZING CONDITIONER
pyrithione zinc lotionProduct Information Item Code (Source) NDC: 82157-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength SAGE (UNII: 065C5D077J) DMDM HYDANTOIN (UNII: BYR0546TOW) BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI) STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR) GLUTAMIC ACID (UNII: 3KX376GY7L) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXYL CINNAMAL (UNII: 7X6O37OK2I) LIMONENE, (+/-)- (UNII: 9MC3I34447) MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID (UNII: 2968PHW8QP) CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0) CARAMEL (UNII: T9D99G2B1R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) MALTODEXTRIN (UNII: 7CVR7L4A2D) GERANIOL (UNII: L837108USY) LINALOOL, (+/-)- (UNII: D81QY6I88E) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PROPYLPARABEN (UNII: Z8IX2SC1OH) PANTHENOL (UNII: WV9CM0O67Z) INOSITOL (UNII: 4L6452S749) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) CELLULOSE GUM (UNII: K679OBS311) GLUCOSE (UNII: 5SL0G7R0OK) SODIUM BENZOATE (UNII: OJ245FE5EU) DIMETHICONE (UNII: 92RU3N3Y1O) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) NIACINAMIDE (UNII: 25X51I8RD4) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) LACTIC ACID (UNII: 33X04XA5AT) BIOTIN (UNII: 6SO6U10H04) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) ETHOXYDIGLYCOL (UNII: A1A1I8X02B) BENZYL ALCOHOL (UNII: LKG8494WBH) METHYLPARABEN (UNII: A2I8C7HI9T) ROSEMARY (UNII: IJ67X351P9) TARTARIC ACID (UNII: W4888I119H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 82157-008-20 200 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M032 12/19/2024 Part 2 of 3 NIOXIN PRO CLINICAL SCALP RECOVERY SCALP SOOTHING SERUM
pyrithione zinc lotionProduct Information Item Code (Source) NDC: 82157-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.1 g in 100 mL Inactive Ingredients Ingredient Name Strength HEXYL CINNAMAL (UNII: 7X6O37OK2I) BENZYL SALICYLATE (UNII: WAO5MNK9TU) CARAMEL (UNII: T9D99G2B1R) GLYCERYL STEARATE (UNII: 230OU9XXE4) GLUCOSE (UNII: 5SL0G7R0OK) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) CETEARYL ALCOHOL (UNII: 2DMT128M1S) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) POLYSORBATE 60 (UNII: CAL22UVI4M) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) BHT (UNII: 1P9D0Z171K) METHYLPARABEN (UNII: A2I8C7HI9T) STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ETHOXYDIGLYCOL (UNII: A1A1I8X02B) CITRIC ACID (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE (UNII: 92RU3N3Y1O) GERANIOL (UNII: L837108USY) DMDM HYDANTOIN (UNII: BYR0546TOW) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) OLEYL ALCOHOL (UNII: 172F2WN8DV) PANTHENOL (UNII: WV9CM0O67Z) TARTARIC ACID (UNII: W4888I119H) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALPHA-ISOMETHYL IONONE (UNII: 9XP4LC555B) SILICA (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D) CELLULOSE GUM (UNII: K679OBS311) LACTIC ACID (UNII: 33X04XA5AT) BENZYL ALCOHOL (UNII: LKG8494WBH) ROSEMARY (UNII: IJ67X351P9) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0) LINALOOL, (+/-)- (UNII: D81QY6I88E) DISODIUM PHOSPHATE (UNII: 22ADO53M6F) LIMONENE, (+/-)- (UNII: 9MC3I34447) PROPYLPARABEN (UNII: Z8IX2SC1OH) MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH) PEG-2M (UNII: V46Y6OJ5QB) SODIUM PHOSPHATE (UNII: SE337SVY37) INOSITOL (UNII: 4L6452S749) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) BIOTIN (UNII: 6SO6U10H04) SAGE (UNII: 065C5D077J) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PHENOXYETHANOL (UNII: HIE492ZZ3T) MALTODEXTRIN (UNII: 7CVR7L4A2D) WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 82157-009-01 100 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M032 12/19/2024 Part 3 of 3 NIOXIN PRO CLINICAL SCALP RECOVERY PURIFYING
pyrithione zinc shampooProduct Information Item Code (Source) NDC: 82157-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 g in 100 mL Inactive Ingredients Ingredient Name Strength PANTHENOL (UNII: WV9CM0O67Z) MAGNESIUM LAURETH-8 SULFATE (UNII: 2OTJ9LF5UA) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) TARTARIC ACID (UNII: W4888I119H) BENZOIC ACID (UNII: 8SKN0B0MIM) SAGE (UNII: 065C5D077J) MAGNESIUM OLETH SULFATE (UNII: LCQ4WP3DTL) PEG-3 DISTEARATE (UNII: 8420ECX438) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLUCOSE (UNII: 5SL0G7R0OK) SODIUM LAURETH-8 SULFATE (UNII: YP8U3694P0) SODIUM BENZOATE (UNII: OJ245FE5EU) FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI) BIOTIN (UNII: 6SO6U10H04) ROSEMARY (UNII: IJ67X351P9) SODIUM OLETH SULFATE (UNII: 3MX3FTR4XP) WATER (UNII: 059QF0KO0R) MALTODEXTRIN (UNII: 7CVR7L4A2D) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INOSITOL (UNII: 4L6452S749) LIMONENE, (+/-)- (UNII: 9MC3I34447) BENZYL ALCOHOL (UNII: LKG8494WBH) CITRIC ACID (UNII: 2968PHW8QP) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) HEXYL CINNAMAL (UNII: 7X6O37OK2I) ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N) GERANIOL (UNII: L837108USY) NIACINAMIDE (UNII: 25X51I8RD4) LACTIC ACID (UNII: 33X04XA5AT) CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH) LINALOOL, (+/-)- (UNII: D81QY6I88E) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ETHOXYDIGLYCOL (UNII: A1A1I8X02B) MAGNESIUM LAURETH SULFATE (UNII: UKW9G007TZ) DMDM HYDANTOIN (UNII: BYR0546TOW) SODIUM HYDROXIDE (UNII: 55X04QC32I) CELLULOSE GUM (UNII: K679OBS311) POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CARAMEL (UNII: T9D99G2B1R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 82157-007-20 200 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M032 12/19/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M032 12/19/2024 Labeler - Wella Operations US LLC (117781338) Establishment Name Address ID/FEI Business Operations kdc/one Chatsworth, Inc. 118542196 manufacture(82157-010)
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