Garnier Fructis Antidandruff by L'Oreal USA Florence Manufacturing Drug Facts

Garnier Fructis Antidandruff by

Drug Labeling and Warnings

Garnier Fructis Antidandruff by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Florence Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GARNIER FRUCTIS ANTIDANDRUFF- pyrithione zinc shampoo 
L'Oreal USA Florence Manufacturing

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

helps eliminate recurrence of scalp itching and flaking due to 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
• wet hair and lather
• massage onto scalp
• rinse and repeat if desired

GARNIER FRUCTIS ANTIDANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67718-942
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)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
COCO-BETAINE (UNII: 03DH2IZ3FY)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
APPLE (UNII: B423VGH5S9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SALICYLIC ACID (UNII: O414PZ4LPZ)
NIACINAMIDE (UNII: 25X51I8RD4)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SUGARCANE (UNII: 81H2R5AOH3)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
METHYL COCOATE (UNII: 92396UOJ5Z)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LEMON PEEL (UNII: 72O054U628)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67718-942-01	384 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2010	07/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/01/2010	07/01/2013

Labeler - L'Oreal USA Florence Manufacturing (960317444)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Florence Manufacturing		960317444	manufacture(67718-942)

Revised: 1/2020

Document Id: 1be046ce-da01-44ae-9b8c-5e4669e1e98e

34390-5

Set id: 92ecc6a7-de8c-455e-8592-d1ee393b6843

Version: 2

Effective Time: 20200128

 

L'Oreal USA Florence Manufacturing