LOreal Professionnel Paris by L'Oreal Productos Capilares Drug Facts

LOreal Professionnel Paris by

Drug Labeling and Warnings

LOreal Professionnel Paris by is a Otc medication manufactured, distributed, or labeled by L'Oreal Productos Capilares. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LOREAL PROFESSIONNEL PARIS INSTANT CLEAR ANTIDANDRUFF- pyrithione zinc shampoo 
L'Oreal Productos Capilares

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

• helps prevent recurrence of the symptoms of dandruff
• helps eliminate scalp flaking and itching associated with dandruff
  

Directions

• for best results, use at least twice a week or as directed by a physician
• shake well
• wet hair and apply a small amount of shampoo
• massage vigorously
• rinse well
• repeat if necessary
  

Warnings

Stop use and ask a doctor if

condition worsens or does not improve after regular use

Warnings

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

When using this product

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Warnings

Stop use and ask a doctor if

condition worsens or does not improve after regular use

Warnings

For external use only

Inactive ingredients

water, sodium laureth sulfate, cocamidopropyl betaine, glycerin, dimethicone, cetyl alcohol, hydroxystearyl cetyl ether, sodium chloride, cocamide MIPA, carbomer, polyquaternium-10, bisabolol, sodium methylparraben, DMDM hydantoin, niacinamide, propylene glycol, methylparaben, hydrosypropyltrimonium hydrolyzed wheat protein, famesol, magnesium sulfate, butylparaben, ethylparaben, methyl cocoate, aspartic acid, glycine, arginine, glutamic acid, propylparaben, isobutylparaben, sodium cocoate

LOREAL PROFESSIONNEL PARIS  INSTANT CLEAR ANTIDANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43325-828
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)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROXYSTEARYL CETYL ETHER (UNII: 8T223890VK)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
LEVOMENOL (UNII: 24WE03BX2T)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
DMDM HYDANTOIN (UNII: BYR0546TOW)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
METHYL COCOATE (UNII: 92396UOJ5Z)
ASPARTIC ACID (UNII: 30KYC7MIAI)
GLYCINE (UNII: TE7660XO1C)
ARGININE (UNII: 94ZLA3W45F)
GLUTAMIC ACID (UNII: 3KX376GY7L)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
SODIUM COCOATE (UNII: R1TQH25F4I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43325-828-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2011	01/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	03/03/2011	01/01/2014

Labeler - L'Oreal Productos Capilares (633333356)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal Productos Capilares		633333356	manufacture(43325-828)

Revised: 1/2020

Document Id: 3813c8fa-00d6-483a-98a9-c6a98aa683b3

34390-5

Set id: 3693588f-4fa0-4fa0-a895-5c0d189a74ec

Version: 4

Effective Time: 20200124