REDKEN 5TH AVENUE NYC SCALP RELIEF DANDRUFF CONTROL- pyrithione zinc shampoo

Redken 5th Avenue NYC Scalp Relief Dandruff Control by

Drug Labeling and Warnings

Redken 5th Avenue NYC Scalp Relief Dandruff Control 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

fights scalp itching, irritation, redness 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 physician

- apply to wet or dry hair, massaging into scalp

- leave on 5 minutes; wet hair, lather and rinse

- can be used daily

Inactive ingredients

water, sodium laureth sulfate, cocamidopropyl betaine, glycerin, acrylates copolymer, PEG-55 propylene glycol oleate, disodium ricinoleamido mea-sulfosuccinate, propylene glycol, sodium chloride, glyceryl laurate, fragrance, sodium benzoate, methylparaben, polyquaternium-10, butylparaben, menthoxypropanediol, ethylparaben, propylparaben, hydrolyzed soy protein, hexyl cinnamal, PPG-5-ceteth-20, linalool, eugenol, limonene, oleth-10, butylphenyl methylpropional, disodium cocoamphodipropionate, lecithin, phosphoric acid, lavandula angustifolia (lavender) oil, phenoxyethanol, sodium hydroxide, citric acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REDKEN 5TH AVENUE NYC SCALP RELIEF DANDRUFF CONTROL 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-795
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)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERYL LAURATE (UNII: Y98611C087)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
EUGENOL (UNII: 3T8H1794QW)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
OLETH-10 (UNII: JD797EF70J)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHOSPHORIC ACID (UNII: E4GA8884NN)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-795-01	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/17/2006

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC.		960317444	manufacture(49967-795)