MIZANI SCALP CARE ANTIDANDRUFF- pyrithione zinc shampoo

Mizani Scalp Care Antidandruff by

Drug Labeling and Warnings

Mizani Scalp Care Antidandruff by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pyrithione zinc 1%

Purpose

Antidandruff

Use

helps eliminate recurrence of scalp flaking, scaling, and itching associated with dandruff

Warnings

For external use only

When using this product

do not getinto eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and consult a physician if

condition worsents or does not improve after regular use

Keep 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 physican
• wet hair and apply 1 - 2 ounces throughout entire head
• massage vigorously
• leave on scalp 1 to 3 minutes
• rinse well
• repeat if necessary

Inactive ingredients

water, sodium laureth sulfate, coco-betaine, glycol distearate, dimethicone, sodium chloride, glycerin, disodium cocoamphodiacetate, fragrance, sodium benzoate, methylparaben, polyquaternium-10, carbomer, cocamide MIPA, salicylic acid, menthol, ethylparaben, benzyl benzoate, benzyl alcohol, benzyl salicylate, citronellol, geraniol, mentha piperita (peppermint) oil, alpha-isomethyl ionone, methyl cocoate, sodium cocoate, rosmarinus officinalis (rosemary) leaf oil, pelargonium graveolens flower oil, lavandula hybrida oil, cucumis sativus (cucumber) fruit extract, sodium hydroxide, curcuma longa (turmeric) root extract, sclareolide, rose flower oil, jasminum officinale (jasmine) extract, citric acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIZANI SCALP CARE ANTIDANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-388
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO-BETAINE (UNII: 03DH2IZ3FY)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
CARBOMER 940 (UNII: 4Q93RCW27E)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
SALICYLIC ACID (UNII: O414PZ4LPZ)
MENTHOL (UNII: L7T10EIP3A)
ETHYLPARABEN (UNII: 14255EXE39)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
PEPPERMINT OIL (UNII: AV092KU4JH)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
METHYL COCOATE (UNII: 92396UOJ5Z)
SODIUM COCOATE (UNII: R1TQH25F4I)
ROSEMARY OIL (UNII: 8LGU7VM393)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
LAVANDIN OIL (UNII: 9RES347CKG)
CUCUMBER (UNII: YY7C30VXJT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TURMERIC (UNII: 856YO1Z64F)
SCLAREOLIDE (UNII: 37W4O0O6E6)
ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-388-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/01/2008

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		960317444	manufacture(49967-388)

Establishment
Name	Address	ID/FEI	Business Operations
Unette Corporation		011401882	pack(49967-388)