Nioxin ® Scalp Recovery ® Soothing Serum

Nioxin ® Scalp Recovery ® Soothing Serum

Drug Labeling and Warnings

Drug Details

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NIOXIN SCALP RECOVERY  SOOTHING SERUM- pyrithione zinc lotion/shampoo 
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 ®

Soothing Serum

Drug Facts

Active ingredient

Pyrithione Zinc 0.1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Uses

  • helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.

Warnings

For external use only.

Ask a doctor before use if you have a condition that covers a large area of the body.

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

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

Inactive ingredients

water, stearamidopropyl dimethylamine, cetyl alcohol, hydroxyethylcellulose, quaternium-18, benzyl alcohol, phenoxyethanol, stearyl alcohol, PEG-2M, dimethicone, cetearyl alcohol, methylparaben, propylparaben, fragrance, glyceryl stearate, oleyl alcohol, citric acid, polysorbate 60, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, yeast extract, camellia sinensis leaf extract, lecithin, PPG-26-buteth-26, saccharomyces/magnesium ferment, dimethyl isosorbide, carnitine HCL, PEG/PPG-18/18 dimethicone, ethoxydiglycol, 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 - 100 mL Bottle Carton

NIOXIN ®
SCALP RECOVERY ®

For a dry, itchy scalp

PYRITHIONE ZINC
DANDRUFF AND
SEBORRHEIC
DERMATITIS
TREATMENT

SOOTHING
SERUM

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

100 mL (3.38 FL OZ)

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
NIOXIN SCALP RECOVERY   SOOTHING SERUM
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69282-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
QUATERNIUM-18 (UNII: O7757NO1VL)  
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)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
LEVOCARNITINE HYDROCHLORIDE (UNII: J3Y5E6IKS3)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
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: 69282-006-501 in 1 CARTON07/01/2016
150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 69282-006-101 in 1 CARTON07/01/2016
2100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
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(69282-006)

Revised: 2/2019
 
The Wella Corporation


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