REDKEN BREWS NYC GROOMING PYRITHIONE ZINC ANTI-DANDRUFF- pyrithione zinc shampoo

Redken Brews NYC Grooming Pyrithione Zinc Anti-dandruff by

Drug Labeling and Warnings

Redken Brews NYC Grooming Pyrithione Zinc Anti-dandruff by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA, INC., Universal Packaging Systems Inc., Unette Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Uses

• for the relief of the symptoms of dandruff
• helps prevent recurrence of the symptoms of dandruff
• controls scalp itching, irritation, redness, flaking, and scaling associated with dandruff

Warnings

For external use only

Ask a doctor before use

in children under 2 years of age

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 doctor
• shake well before each use
• wet hair and apply a small amount of shampoo
• apply evely to scalp, leave on for several minutes, and then rinse off

Inactive ingredients

water, sodium laureth sulfate, sodium lauryl sulfate, glycerin, cocamide MEA, glycol distearate, sodium chloride, hexylene glycol, dimethicone, citric acid, fragrance, sodium benzoate, sodium hydroxide, coco-betaine, carbomer, guar hydroxypropyltrimonium chloride, menthoxypropanediolm sodium polynaphthalenesulfonate, salicylic acid, hydrolyzed soy protein, eugenol, limonene, cellulose gum, lecithin, fumaric acid, phosphoric acid, lavandula angustifolia (lavender) oil, methylisothiazolinone

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REDKEN BREWS NYC GROOMING PYRITHIONE ZINC ANTI-DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-183
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)
sodium lauryl sulfate (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DIMETHICONE (UNII: 92RU3N3Y1O)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
sodium benzoate (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COCO-BETAINE (UNII: 03DH2IZ3FY)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
SALICYLIC ACID (UNII: O414PZ4LPZ)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
EUGENOL (UNII: 3T8H1794QW)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED form (UNII: K679OBS311)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
FUMARIC ACID (UNII: 88XHZ13131)
PHOSPHORIC ACID (UNII: E4GA8884NN)
LAVENDER OIL (UNII: ZBP1YXW0H8)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-183-01	300 mL in 1 TUBE; Type 0: Not a Combination Product	07/02/2018
2	NDC: 49967-183-02	1000 mL in 1 TUBE; Type 0: Not a Combination Product	07/02/2018
3	NDC: 49967-183-03	50 mL in 1 TUBE; Type 0: Not a Combination Product	07/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/02/2018

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC.		960317444	manufacture(49967-183) , pack(49967-183)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems Inc.		078717086	pack(49967-183)

Establishment
Name	Address	ID/FEI	Business Operations
Unette Corporation		011401882	pack(49967-183)