Kiehls Since 1851 Scalp Purifying Dandruff: Package Insert and Label Information

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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM LAURETH SULFATE
DISODIUM COCOAMPHODIACETATE
SODIUM CHLORIDE
GLYCOL DISTEARATE
PPG-5-CETETH-20
SODIUM BENZOATE
CARBOXYPOLYMETHYLENE
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)
SALICYLIC ACID
MENTHOL
CITRIC ACID MONOHYDRATE
ROSEMARY OIL
THYMUS MASTICHINA FLOWERING TOP OIL
LINALOOL, (+/-)-
ALOE VERA LEAF
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-799-01 250 mL in 1 BOTTLE None
2 NDC:49967-799-02 5 mL in 1 PACKET None
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 Operations
L’Oreal USA, Inc. 185931458 manufacture (49967-799)

Revised: 01/2020 L’Oreal USA Products Inc

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