NIOXIN SCALP OPTIMIZING CLEANSER ADVANCED THINNING- pyrithione zinc shampoo

Nioxin Scalp Optimizing Cleanser by

Drug Labeling and Warnings

Nioxin Scalp Optimizing Cleanser by is a Otc medication manufactured, distributed, or labeled by The Wella Corporation, Coty US LLC, Thibiant International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Pyrithione zinc 1%

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.
• for maximum dandruff control, use every time you shampoo.
• shake before use.
• wet hair, massage onto scalp, 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, methylchloroisothiazolinone, saccharomyces/zinc ferment, methylisothiazolinone.

Questions (or comments)?

1-800-935-5273

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

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

NIOXIN®

PYRITHIONE ZINC
DANDRUFF SHAMPOO

SCALP OPTIMIZING
CLEANSER

advanced
thinning

96974610

CLEARS SCALP
TO REDUCE DAMAGE
ON NEW HAIR

6.7 FL OZ (200 mL)

INGREDIENTS AND APPEARANCE

NIOXIN SCALP OPTIMIZING CLEANSER   ADVANCED THINNING
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69282-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)
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 (UNII: 3NY3SM6B8U)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69282-004-50	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2014
2	NDC: 69282-004-20	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2014
3	NDC: 69282-004-10	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/10/2014

Labeler - The Wella Corporation (829413157)

Registrant - Coty US LLC (039056361)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	manufacture(69282-004)