Nioxin ® Scalp Recovery ® Medicating Cleanser

Nioxin ® Scalp Recovery ® Medicating Cleanser

Drug Labeling and Warnings

Drug Details

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NIOXIN SCALP RECOVERY  MEDICATING CLEANSER- pyrithione zinc lotion 
The Wella Corporation

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 0.5%

Purpose

Anti-dandruff

Uses

  • helps prevent recurrence of flaking and itching associated with dandruff.

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

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 ingredients

WATER, STEARYL ALCOHOL, CETYL ALCOHOL, STEARAMIDOPROPYL DIMETHYLAMINE, DIMETHICONE, GLUTAMIC ACID, BENZYL ALCOHOL, PHENOXYETHANOL, FRAGRANCE, PROPYLPARABEN, METHYLPARABEN, CITRIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, MENTHA ARVENSIS LEAF OIL, MENTHOL, YEAST EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, LECITHIN, PPG-26-BUTETH-26, SACCHAROMYCES/MAGNESIUM FERMENT, DIMETHYL ISOSORBIDE, PEG/PPG-18/18 DIMETHICONE, ETHOXYDIGLYCOL, CARNITINE HCL, ORYZA SATIVA (RICE) BRAN, PEG-40 HYDROGENATED CASTOR OIL, BIOTIN/FOLIC ACID/CYANOCOBALAMIN/NIACINAMIDE/PANTOTHENIC ACID/PYRIDOXINE/RIBOFLAVIN/THIAMINE/YEAST POLYPEPTIDES, SACCHAROMYCES/IRON FERMENT, SACCHAROMYCES/COPPER FERMENT, SACCHAROMYCES/SILICON FERMENT, SACCHAROMYCES/ZINC FERMENT, ACACIA SENEGAL GUM, UBIQUINONE.

Questions?

1-800-935-5273

Dist. by THE WELLA
CORPORATION, WOODLAND
HILLS, CA 91367

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

NIOXIN ®
SCALP RECOVERY ®

For a dry, itchy scalp

PYRITHIONE ZINC
DANDRUFF
CONDITIONER

MOISTURIZING
CONDITIONER

100% FLAKE FREE
ELIMINATION OF
VISIBLE FLAKES WITH
REGULAR USE*

99864275

200 mL (6.76 FL OZ)

Principal Display Panel - 200 mL Bottle Label
NIOXIN SCALP RECOVERY   MEDICATING CLEANSER
pyrithione zinc lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69282-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLUTAMIC ACID (UNII: 3KX376GY7L)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
LEVOCARNITINE HYDROCHLORIDE (UNII: J3Y5E6IKS3)  
RICE BRAN (UNII: R60QEP13IC)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
ACACIA (UNII: 5C5403N26O)  
UBIDECARENONE (UNII: EJ27X76M46)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69282-007-501 in 1 CARTON07/01/2016
150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 69282-007-20200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2016
3NDC: 69282-007-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/01/2016
Labeler - The Wella Corporation (829413157)
Registrant - Coty US LLC (039056361)
Establishment
NameAddressID/FEIBusiness Operations
Thibiant International, Inc.083913913manufacture(69282-007)

Revised: 2/2019
 
The Wella Corporation


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