NIOXIN

Main information

  • Trade name:
  • NIOXIN SCALP RECOVERY MEDICATING CLEANSER pyrithione zinc lotion/ shampoo
  • Composition:
  • PYRITHIONE ZINC 1 mg in 1 mL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NIOXIN SCALP RECOVERY MEDICATING CLEANSER pyrithione zinc lotion/shampoo
    United States
  • Language:
  • English

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Last update:
  • 15-01-2018

Summary of Product characteristics: dosage, interactions, side effects

NIOXIN SCALP RECOVERY MEDICATING CLEANSER- pyrithione zinc lotion/shampoo

The Procter & Gamble Manufacturing Company

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 0.1%

Purpos e

Anti-dandruff, Anti-seborrheic dermatitis

Us es

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.

Ques tions ?

1-800-935-5273

DISTR. BY

THE WELLA

CORPORATION,

WOODLAND HILLS,

CA 91367

PRINCIPAL DISPLAY PANEL - 1 L 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

REDUCES HAIR BREAKAGE

FROM SCALP ITCHING

HELPS SOOTHE DRY SCALP

OVER TIME

99312360

1 L (3.38 FL OZ)

®

®

NIOXIN SCALP RECOVERY MEDICATING CLEANSER

pyrithione zinc lotion/shampoo

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:370 0 0 -739

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PYRITHIO NE ZINC (UNII: R9 53O2RHZ5) (PYRITHIONE ZINC - UNII:R9 53O2RHZ5)

PYRITHIONE ZINC

1 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM LAURETH-3 SULFATE (UNII: BPV39 0 UAP0 )

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

CO CO MO NO ETHANO LAMIDE (UNII: C8 0 6 8 4146 D)

ZINC CARBO NATE (UNII: EQR32Y7H0 M)

GLYCO L DISTEARATE (UNII: 13W7MDN21W)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

GUAR HYDRO XYPRO PYLTRIMO NIUM CHLO RIDE ( 1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16 G315W7A)

SO DIUM XYLENESULFO NATE (UNII: G4LZF9 50 UR)

MAGNESIUM SULFATE, UNSPECIFIED FO RM (UNII: DE0 8 0 37SAB)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

The Procter & Gamble Manufacturing Company

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A)

MENTHA ARVENSIS LEAF O IL (UNII: 1AEY1M553N)

MAGNESIUM CARBO NATE HYDRO XIDE (UNII: YQO0 29 V1L4)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

YEAST, UNSPECIFIED (UNII: 3NY3SM6 B8 U)

BIO TIN (UNII: 6 SO6 U10 H0 4)

FO LIC ACID (UNII: 9 35E9 7BOY8 )

CYANO CO BALAMIN (UNII: P6 YC3EG20 4)

NIACINAMIDE (UNII: 25X51I8 RD4)

PANTO THENIC ACID (UNII: 19 F5HK2737)

PYRIDO XINE (UNII: KV2JZ1BI6 Z)

RIBO FLAVIN (UNII: TLM29 76 OFR)

THIAMINE (UNII: X6 6 NSO3N35)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:370 0 0 -739 -

50 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/0 1/20 11

0 7/0 1/20 18

2

NDC:370 0 0 -739 -

20 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/0 1/20 11

0 7/0 1/20 18

3

NDC:370 0 0 -739 -

10 0 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/0 1/20 11

0 7/0 1/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

0 1/0 1/20 11

0 7/0 1/20 18

Labeler -

T he Procter & Gamble Manufacturing Company (004238200)

Revised: 3/2017