KIEHLS SINCE 1851 SCALP PURIFYING 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 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

image of a label

KIEHLS SINCE 1851 SCALP PURIFYING DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-799
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-799-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2012
2NDC:49967-799-025 mL in 1 PACKET; Type 0: Not a Combination Product06/04/201206/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/04/201206/02/2019
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.185931458manufacture(49967-799)

Revised: 1/2023
Document Id: f3b0702d-0b91-434e-ab73-b965db06250f
Set id: d11d5ca3-076b-46b6-a5a2-9cf7dd534ece
Version: 5
Effective Time: 20230127
 
L'Oreal USA Products Inc