Label: NIOXIN SCALP RECOVERY ANTI-DANDRUFF SYSTEM- pyrithione zinc kit
- NDC Code(s): 82157-003-20, 82157-004-20, 82157-005-10, 82157-006-99
- Packager: Wella Operations US LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 1, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
MEDICATING CLEANSER
- For best results, use at least twice a week or as directed by a doctor
- Use daily for maximum dandruff control
- 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
- Use daily for maximum dandruff control
- Apply to wet scalp and hair. Leave for 1-3 minutes. Rinse well.
SOOTHING SERUM
- Apply after usage of Medicating Cleanser and Moisturizing Conditioner to scalp.
- Apply to affected areas one to four times daily or as directed by a doctor.
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INACTIVE INGREDIENT
MEDICATING CLEANSER
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.
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NIOXIN SCALP RECOVERY ANTI-DANDRUFF SYSTEM
pyrithione zinc kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82157-006 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82157-006-99 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 12/01/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 200 mL Part 2 1 BOTTLE, PLASTIC 200 mL Part 3 1 BOTTLE, PLASTIC 100 mL Part 1 of 3 NIOXIN SCALP RECOVERY MEDICATING CLEANSER
pyrithione zinc shampooProduct Information Item Code (Source) NDC:82157-003 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 LECITHIN, SOYBEAN (UNII: 1DI56QDM62) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) MAGNESIUM LAURETH SULFATE (UNII: UKW9G007TZ) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INOSITOL (UNII: 4L6452S749) LACTIC ACID (UNII: 33X04XA5AT) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM BENZOATE (UNII: OJ245FE5EU) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) BENZYL ALCOHOL (UNII: LKG8494WBH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LIMONENE, (+/-)- (UNII: 9MC3I34447) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CHLORIDE (UNII: 451W47IQ8X) FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURETH-8 SULFATE (UNII: YP8U3694P0) SAGE (UNII: 065C5D077J) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) MALTODEXTRIN (UNII: 7CVR7L4A2D) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) CARAMEL (UNII: T9D99G2B1R) NIACINAMIDE (UNII: 25X51I8RD4) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) SODIUM OLEYL SULFATE (UNII: 46F21X4586) MAGNESIUM OLETH SULFATE (UNII: LCQ4WP3DTL) DMDM HYDANTOIN (UNII: BYR0546TOW) PEPPERMINT OIL (UNII: AV092KU4JH) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GERANIOL (UNII: L837108USY) BIOTIN (UNII: 6SO6U10H04) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BENZOIC ACID (UNII: 8SKN0B0MIM) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) TARTARIC ACID (UNII: W4888I119H) PANTHENOL (UNII: WV9CM0O67Z) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) LINALOOL, (+/-)- (UNII: D81QY6I88E) WATER (UNII: 059QF0KO0R) PEG-3 DISTEARATE (UNII: 8420ECX438) POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) ROSEMARY (UNII: IJ67X351P9) ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N) MAGNESIUM LAURETH-8 SULFATE (UNII: 2OTJ9LF5UA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82157-003-20 200 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 final M032 12/01/2022 Part 2 of 3 NIOXIN SCALP RECOVERY MOISTURIZING CONDITIONER
pyrithione zinc lotionProduct Information Item Code (Source) NDC:82157-004 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 LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SAGE (UNII: 065C5D077J) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ROSEMARY (UNII: IJ67X351P9) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) INOSITOL (UNII: 4L6452S749) TARTARIC ACID (UNII: W4888I119H) LIMONENE, (+/-)- (UNII: 9MC3I34447) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) PHENOXYETHANOL (UNII: HIE492ZZ3T) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) GERANIOL (UNII: L837108USY) FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI) PROPYLPARABEN (UNII: Z8IX2SC1OH) PEPPERMINT OIL (UNII: AV092KU4JH) NIACINAMIDE (UNII: 25X51I8RD4) DMDM HYDANTOIN (UNII: BYR0546TOW) LACTIC ACID (UNII: 33X04XA5AT) SODIUM BENZOATE (UNII: OJ245FE5EU) CARAMEL (UNII: T9D99G2B1R) LINALOOL, (+/-)- (UNII: D81QY6I88E) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PANTHENOL (UNII: WV9CM0O67Z) BIOTIN (UNII: 6SO6U10H04) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETYL ALCOHOL (UNII: 936JST6JCN) STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR) GLUTAMIC ACID (UNII: 3KX376GY7L) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82157-004-20 200 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 final M032 12/01/2022 Part 3 of 3 NIOXIN SCALP RECOVERY SOOTHING SERUM
pyrithione zinc lotionProduct Information Item Code (Source) NDC:82157-005 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 URTICA DIOICA LEAF (UNII: X6M0DRN46Q) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) CETYL ALCOHOL (UNII: 936JST6JCN) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) ROSEMARY (UNII: IJ67X351P9) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LIMONENE, (+/-)- (UNII: 9MC3I34447) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PANTHENOL (UNII: WV9CM0O67Z) NIACINAMIDE (UNII: 25X51I8RD4) LINALOOL, (+/-)- (UNII: D81QY6I88E) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI) WATER (UNII: 059QF0KO0R) CARAMEL (UNII: T9D99G2B1R) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) METHYLPARABEN (UNII: A2I8C7HI9T) PEPPERMINT OIL (UNII: AV092KU4JH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) DIMETHICONE (UNII: 92RU3N3Y1O) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BIOTIN (UNII: 6SO6U10H04) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR) POLYSORBATE 60 (UNII: CAL22UVI4M) POLYETHYLENE OXIDE 100000 (UNII: V46Y6OJ5QB) OLEYL ALCOHOL (UNII: 172F2WN8DV) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) DMDM HYDANTOIN (UNII: BYR0546TOW) MALTODEXTRIN (UNII: 7CVR7L4A2D) TARTARIC ACID (UNII: W4888I119H) SAGE (UNII: 065C5D077J) SODIUM BENZOATE (UNII: OJ245FE5EU) INOSITOL (UNII: 4L6452S749) BENZYL SALICYLATE (UNII: WAO5MNK9TU) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SODIUM PHOSPHATE (UNII: SE337SVY37) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) GERANIOL (UNII: L837108USY) BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) LACTIC ACID (UNII: 33X04XA5AT) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82157-005-10 100 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 final M032 12/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M032 12/01/2022 Labeler - Wella Operations US LLC (117781338)
