NIOXIN SCALP RECOVERY MEDICATING CLEANSER- pyrithione zinc shampoo 
Wella Operations US LLC

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.

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Nioxin Scalp Recovery Medicating Cleanser

Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

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.

Directions

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?

1-800-935-5273

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

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)

82157-003 PDP

82157-003 back rev

NIOXIN SCALP RECOVERY MEDICATING CLEANSER 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82157-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82157-003-20200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03212/01/2022
Labeler - Wella Operations US LLC (117781338)

Revised: 12/2022
Document Id: eee1f553-e6cf-963e-e053-2a95a90a8037
Set id: e4f87c14-2d50-82be-e053-2995a90a8930
Version: 2
Effective Time: 20221202
 
Wella Operations US LLC