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

Drug Details [pdf]

GARNIER FRUCTIS ANTIDANDRUFF DRY SCALP- 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

Inactive ingredients

water, sodium laureth sulfate, cocamide MPA, coco-betaine, glycol distearate, sodium chloride, dimethicone, pyrus malus (apple) fruit extract, sodium benzoate, salicylic acid, carbomer, niacinamide, pyridoxine HCL, aloe barbadensis leaf juice, citric acid, linalool, limonene, saccharum officianum (sugar cane) extract, salix nigra (willow) bark extract, guar hydroxypropyltrimonium chloride, methyl cocoate, hexyl cinnamal, benzyl alcohol, benzyl salicylate, sodium cocoate, sodium hydroxide, citrus medica limonum (lemon) peel extract, camellia sinensis leaf extract, blue 1

image description

GARNIER FRUCTIS ANTIDANDRUFF DRY SCALP
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67718-943
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 67718-943-01	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2010	07/01/2013

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

Labeler - L'Oreal USA Florence Manufacturing (960317444)

Name	Address	ID/FEI	Business Operations
Establishment
L'Oreal USA Florence Manufacturing		960317444	manufacture(67718-943)

Revised: 1/2020

Document Id: 7bbefef2-1e76-4997-90b7-a4a699f096df

Set id: 69dbb43f-854f-406f-a9ea-0253637db251

Version: 2

Effective Time: 20200128

L'Oreal USA Florence Manufacturing