REDKEN BREWS NYC GROOMING PYRITHIONE ZINC ANTI-DANDRUFF- pyrithione zinc shampoo 
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

image of a label

REDKEN BREWS NYC GROOMING PYRITHIONE ZINC ANTI-DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-183
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-183-01300 mL in 1 TUBE; Type 0: Not a Combination Product07/02/201802/01/2021
2NDC:49967-183-021000 mL in 1 TUBE; Type 0: Not a Combination Product07/02/201810/01/2020
3NDC:49967-183-0350 mL in 1 TUBE; Type 0: Not a Combination Product07/02/201807/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/02/201802/01/2021
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA, INC.960317444manufacture(49967-183) , pack(49967-183)
Establishment
NameAddressID/FEIBusiness Operations
Unette Corporation011401882pack(49967-183)

Revised: 5/2021
 
L'Oreal USA Products Inc