NIOXIN SCALP RECOVERY ANTI-DANDRUFF SYSTEM- pyrithione zinc kit

Nioxin Scalp Recovery Anti-Dandruff System by

Drug Labeling and Warnings

Nioxin Scalp Recovery Anti-Dandruff System by is a Otc medication manufactured, distributed, or labeled by Wella Operations US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Pyrithione zinc 1% (Medicating Cleanser)

Pyrithione zinc 0.5% (Moisturizing Conditioner)

Pyrithione zinc 0.1% (Soothing Serum)

PURPOSE

Purpose

Anti-dandruff

INDICATIONS & USAGE

Uses

• helps prevent recurrence of flaking and itching associated with dandruff

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

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.

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

Questions?

1-800-935-5273

SPL UNCLASSIFIED SECTION

MADE IN U.S.A. of U.S. and/or imported ingredients

Dist. Wella Operations US LLC,

Calabasas, CA 91302

www.nioxin.com

1-800-935-5273

PRINCIPAL DISPLAY PANEL

NIOXIN®

SCALP RECOVERY

ANTI-DANDRUFF SYSTEM FOR ITCHY, FLAKY SCALP

COMBATS DANDRUFF FROM THE 1ST USE

STEP 1	STEP 2	STEP 3
PYRITHIONE ZINC MEDICATING CLEANSER	PYRITHIONE ZINC MOISTURIZING CONDITIONER	PYRITHIONE ZINC SOOTHING SERUM
200 mL (6.76 FL OZ )	200 mL ( 6.76 FL OZ)	100 mL ( 3.38 FL OZ)

INGREDIENTS AND APPEARANCE

NIOXIN SCALP RECOVERY ANTI-DANDRUFF SYSTEM 
pyrithione zinc kit

Product 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 shampoo

Product 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 lotion

Product 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 lotion

Product 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)