MIZANI SCALP CARE CONDITIONER ANTIDANDRUFF CONDITIONER- pyrithione zinc lotion

Mizani Scalp Care Conditioner Antidandruff Conditioner by

Drug Labeling and Warnings

Mizani Scalp Care Conditioner Antidandruff Conditioner by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc., Unette Corporation. 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 get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and consult a physician if

condition worsens 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 physician
• wet hair and apply 1 - 2 ounces throughout entire head
• massage gently into hair and scalp
• cover hair with plastic cap and leave on for 10 minutes
• rinse well
• towel dry
• style as desired

Inactive ingredients

water, cetearyl alcohol, behentrimonium chloride, glycerin, PEG-180, amodimethicone, cetyl esters, isopropyl alcohol, fragrance, methylparaben, hydroxyethylcellulose, menthol, trideceth-6, benzyl benzoate, benzyl alcohol, benzyl salicylate, chlorhexidine dihydrochloride, citronellol, cetrimonium chloride, geraniol, mentha piperita (peppermint) oil, alpha-isomethyl ionone, rosmarinus officinalis (rosemary) leaf oil, pelargonium graveolens flower oil, lavandula hybrida oil, cucumis sativus (cucumber) fruit extract, curcuma longa (turmeric) root extract, sclareolide, rose flower oil, jasminum officinale (jasmine) extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIZANI SCALP CARE CONDITIONER ANTIDANDRUFF CONDITIONER 
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-389
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)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
MENTHOL (UNII: L7T10EIP3A)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
CHLORHEXIDINE HYDROCHLORIDE (UNII: E64XL9U38K)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
GERANIOL (UNII: L837108USY)
PEPPERMINT OIL (UNII: AV092KU4JH)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
ROSEMARY OIL (UNII: 8LGU7VM393)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
LAVANDIN OIL (UNII: 9RES347CKG)
CUCUMBER (UNII: YY7C30VXJT)
TURMERIC (UNII: 856YO1Z64F)
SCLAREOLIDE (UNII: 37W4O0O6E6)
ROSE OIL (UNII: WUB68Y35M7)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-389-01	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(49967-389)

Establishment
Name	Address	ID/FEI	Business Operations
Unette Corporation		011401882	pack(49967-389)