NIOXIN PRO CLINICAL SCALP RECOVERY SCALP SOOTHING SERUM- pyrithione zinc lotion

nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum by

Drug Labeling and Warnings

nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum 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 0.1%

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

• Apply to affected areas one to four times daily or as directed by a doctor.

INACTIVE INGREDIENT

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

NIOXIN SCALP RECOVERY™

SCALP SOOTHING SERUM

WITH PYRITHIONE ZINC IS A LEAVE-ON TREATMENT THAT HELPS RELIEVE DANDRUFF.

Made in USA WITH IMPORTED PARTS

Dist Wella Operations US LLC. Calabasas, CA 91302

www.nioxin.com

PRINCIPAL DISPLAY PANEL

NIOXIN®

PRO CLINICAL

SCALP RECOVERY

scalp soothing serum

FOR ANTI-DANDRUFF

FOR ITCHY FLAKY SCALP

COMBATS DANDRUFF FROM THE 1ST USE

WITH PYRITHIONE ZINC

CLINICALLY & DERMATOLOGICALLY TESTED

100 mL (3.3 FL OZ)

INGREDIENTS AND APPEARANCE

NIOXIN PRO CLINICAL SCALP RECOVERY SCALP SOOTHING SERUM 
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	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
WATER (UNII: 059QF0KO0R)
BHT (UNII: 1P9D0Z171K)
ALPHA-ISOMETHYL IONONE (UNII: 9XP4LC555B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
POLYSORBATE 60 (UNII: CAL22UVI4M)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
HEXYL CINNAMAL (UNII: 7X6O37OK2I)
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)
SILICA (UNII: ETJ7Z6XBU4)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM BENZOATE (UNII: OJ245FE5EU)
INOSITOL (UNII: 4L6452S749)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PEG-2M (UNII: V46Y6OJ5QB)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
CARAMEL (UNII: T9D99G2B1R)
METHYLPARABEN (UNII: A2I8C7HI9T)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
BIOTIN (UNII: 6SO6U10H04)
SAGE (UNII: 065C5D077J)
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
CETYL ALCOHOL (UNII: 936JST6JCN)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PANTHENOL (UNII: WV9CM0O67Z)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
DMDM HYDANTOIN (UNII: BYR0546TOW)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE GUM (UNII: K679OBS311)
GLUCOSE (UNII: 5SL0G7R0OK)
LACTIC ACID (UNII: 33X04XA5AT)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
ROSEMARY (UNII: IJ67X351P9)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
TARTARIC ACID (UNII: W4888I119H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CITRIC ACID (UNII: 2968PHW8QP)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
GERANIOL (UNII: L837108USY)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-009-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/19/2024
2	NDC: 82157-009-10	1 in 1 CARTON	12/19/2024
2		100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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)