Nioxin ® Scalp Recovery ® Medicating Cleanser

Nioxin ® Scalp Recovery ® Medicating Cleanser

Drug Labeling and Warnings

Drug Details

k">

NIOXIN SCALP RECOVERY  MEDICATING CLEANSER- 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.

----------

Nioxin ® Scalp Recovery ®

Medicating Cleanser

Drug Facts

Active ingredient

Pyrithione Zinc 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

  • 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, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, DIMETHICONE, CETYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, FRAGRANCE, DMDM HYDANTOIN, MENTHA PIPERITA (PEPPERMINT) OIL, MENTHOL, MENTHA ARVENSIS LEAF OIL, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, CAMELLIA SINENSIS LEAF EXTRACT, YEAST EXTRACT, LECITHIN, SACCHAROMYCES/MAGNESIUM FERMENT, BIOTIN/FOLIC ACID/CYANOCOBALAMIN/NIACINAMIDE/PANTOTHENIC ACID/PYRIDOXINE/RIBOFLAVIN/THIAMINE/YEAST POLYPEPTIDES, SACCHAROMYCES/IRON FERMENT, SACCHAROMYCES/COPPER FERMENT, SACCHAROMYCES/SILICON FERMENT, SACCHAROMYCES/ZINC FERMENT.

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 AND
SEBORRHEIC
DERMATITIS
SHAMPOO

MEDICATING
CLEANSER

100% FLAKE FREE
ELIMINATION OF
VISIBLE FLAKES WITH
REGULAR USE

99405984

200 mL (6.76 FL OZ)

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label
NIOXIN SCALP RECOVERY   MEDICATING CLEANSER
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69282-005
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
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
ZINC CARBONATE (UNII: EQR32Y7H0M)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69282-005-501 in 1 CARTON07/01/2016
150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 69282-005-20200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2016
3NDC: 69282-005-101000 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(69282-005)

Revised: 2/2019
 
The Wella Corporation


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.