NIOXIN SCALP RECOVERY SOOTHING SERUM- pyrithione zinc lotion

Nioxin Scalp Recovery Soothing Serum by

Drug Labeling and Warnings

Nioxin Scalp Recovery 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 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

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® SOOTHING SERUM

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

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®

PYRITHIONE ZINC

SOOTHING SERUM

STEP 3
SCALP RECOVERY

FOR ITCHY FLAKY SCALP

COMBATS DANDRUFF FROM THE 1ST USE

100 mL (3.38 FL OZ)

INGREDIENTS AND APPEARANCE

NIOXIN SCALP RECOVERY SOOTHING SERUM 
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	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
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
ROSEMARY (UNII: IJ67X351P9)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
CETYL ALCOHOL (UNII: 936JST6JCN)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYETHYLENE OXIDE 100000 (UNII: V46Y6OJ5QB)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PEPPERMINT OIL (UNII: AV092KU4JH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
SODIUM BENZOATE (UNII: OJ245FE5EU)
INOSITOL (UNII: 4L6452S749)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
BIOTIN (UNII: 6SO6U10H04)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PANTHENOL (UNII: WV9CM0O67Z)
NIACINAMIDE (UNII: 25X51I8RD4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
DMDM HYDANTOIN (UNII: BYR0546TOW)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
LACTIC ACID (UNII: 33X04XA5AT)
TARTARIC ACID (UNII: W4888I119H)
SAGE (UNII: 065C5D077J)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
CARAMEL (UNII: T9D99G2B1R)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-005-10	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	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)