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 MINT CLEANSE- 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

Directions

• for best results, use at least twice a week or ad directed by a doctor
• wet hair and lather
• massage onto scalp
• rinse and repeat if desired
  

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.

Questions or comments?

1-800-4427643

Inactive ingredients

water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, polyethylene, sodium chloride, glycol distearate, pyrus malus (apple) fruit extract, sodium benzoate, salicylic acid, carbomer, dimethicone, polyquaternium-10, menthol, niacinamide, pyridoxine HCL, chromium hydroxide green, caffeine, citric acid, saccharum officianum (sugar cane) extract, salix nigra (willow) bark extract, hydroxypropyltrimonium hydrolyzed wheat protein, linalool, limonene, coumarin, camellia sinensis leaf extract, yellow 5, citrus medica limonum (lemon) peel extract, blue 1, sodium hydroxide

GARNIER FRUCTIS ANTIDANDRUFF MINT CLEANSE 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67718-893
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)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
APPLE (UNII: B423VGH5S9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
MENTHOL (UNII: L7T10EIP3A)
NIACINAMIDE (UNII: 25X51I8RD4)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
CAFFEINE (UNII: 3G6A5W338E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUGARCANE (UNII: 81H2R5AOH3)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
COUMARIN (UNII: A4VZ22K1WT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
LEMON PEEL (UNII: 72O054U628)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67718-893-01	384 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2011	03/01/2014

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

Labeler - L'Oreal USA Florence Manufacturing (960317444)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Florence Manufacturing		960317444	manufacture(67718-893)

Revised: 1/2020

Document Id: cb5fdbfc-cc97-4b6c-a21b-21dc78410e73

34390-5

Set id: f45ced19-6ac0-4182-a503-a7e332b5b782

Version: 3

Effective Time: 20200128