KIEHLS SINCE 1851 SCALP PURIFYING DANDRUFF- pyrithione zinc shampoo

Kiehls Since 1851 Scalp Purifying Dandruff by

Drug Labeling and Warnings

Kiehls Since 1851 Scalp Purifying Dandruff 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

Uses

• controls the symptoms of dandruff
• reduces recurrence of the symptoms of dandruff
• for the relief of scalp itching, irritation and flaking associated with dandruff

Warnings

For external use only

When using this product

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask 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 physican
• shake well
• wet hair and apply a small amount of shampoo
• massage vigorously
• rinse well

Inactive ingredients

water, sodium laureth sulfate, disodium cocoamphodiacetate, sodium chloride, glycol disearate, PPG-5-ceteth-20, sodium benzoate, carbomer, polyquaternium-10, salicylic acid, methol, citric acid, rosmarinus officinalis (rosemary) leaf oil, thymus mastichina flower oil, linalool, aloe barbadensis leaf juice, sodium hydroxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS SINCE 1851 SCALP PURIFYING DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-799
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)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
SALICYLIC ACID (UNII: O414PZ4LPZ)
MENTHOL (UNII: L7T10EIP3A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ROSEMARY OIL (UNII: 8LGU7VM393)
THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-799-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2012
2	NDC: 49967-799-02	5 mL in 1 PACKET; Type 0: Not a Combination Product	06/04/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/04/2012

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-799)