NIOXIN SCALP RECOVERY MEDICATING CLEANSER- pyrithione zinc shampoo

Nioxin Scalp Recovery Medicating Cleanser by

Drug Labeling and Warnings

Nioxin Scalp Recovery Medicating Cleanser 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%

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

• 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.

INACTIVE INGREDIENT

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.

QUESTIONS

Questions?

1-800-935-5273

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NIOXIN SCALP RECOVERY®

MEDICATING CLEANSER

IS AN ANTIDANDRUFF SHAMPOO WITH PYRITHIONE ZINC THAT HELPS PREVENT AND RELIEVE THE SYMPTOMS OF DANDRUFF, SUCH AS SCALP ITCHING AND FLAKING.

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 MEDICATING CLEANSER

STEP 1

SCALP RECOVERY®
FOR ITCHY, FLAKY SCALP

COMBATS DANDRUFF FROM THE 1ST USE

200 mL (6.76 FL OZ)

INGREDIENTS AND APPEARANCE

NIOXIN SCALP RECOVERY MEDICATING CLEANSER 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	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
POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
SODIUM OLEYL SULFATE (UNII: 46F21X4586)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)
MAGNESIUM LAURETH-8 SULFATE (UNII: 2OTJ9LF5UA)
MAGNESIUM LAURETH SULFATE (UNII: UKW9G007TZ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BIOTIN (UNII: 6SO6U10H04)
SODIUM LAURETH-8 SULFATE (UNII: YP8U3694P0)
GERANIOL (UNII: L837108USY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ROSEMARY (UNII: IJ67X351P9)
INOSITOL (UNII: 4L6452S749)
LACTIC ACID (UNII: 33X04XA5AT)
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SAGE (UNII: 065C5D077J)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
BENZOIC ACID (UNII: 8SKN0B0MIM)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
TARTARIC ACID (UNII: W4888I119H)
CARAMEL (UNII: T9D99G2B1R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM OLETH SULFATE (UNII: LCQ4WP3DTL)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
PEG-3 DISTEARATE (UNII: 8420ECX438)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PEPPERMINT OIL (UNII: AV092KU4JH)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-003-20	200 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)