Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

KERASTASE SPECIFIQUE BAIN EXFOLIANT HYDRATANT- 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

Use

controls the symptoms of 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 doctor 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
• massage in to wet hair, rinse and repeat
  

Inactive ingredients

water, sodium laureth sulfate, sodium lauryl sulfate, glycerin, cocamide MEA, glycol distearate, polyethylene, sodium chloride, dimethicone, sodium benzoate, carbomer, salicylic acid, guar hydroxypropyltrimonium chloride, hexyl cinnamal, ci 77289/chromium hydroxide green, linalool, hydroxycitronellal, benzyl alcohol, citronellol, sodium hydroxide, citric acid, fragrance

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

KERASTASE SPECIFIQUE BAIN EXFOLIANT HYDRATANT 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-483
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)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-483-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2012	09/04/2015
2	NDC: 49967-483-02	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2012	09/04/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/01/2012	09/04/2015

Labeler - L'Oreal USA Products Inc (002136794)

Revised: 8/2019

Document Id: e39c7334-8fb5-4e3e-aa5b-c1ea63e8f71a

34390-5

Set id: 08d8ce11-d30d-4dc6-b87e-94ad7dd94ebd

Version: 6

Effective Time: 20190827