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 CLEAR CONTROL- salicylic acid 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

Salicylic acid 3%

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 as 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?

1-800-442-7643

Inactive ingredients

water, sodium laureth sulfate, PEG-150 distearate, cocamidopropyl betaine, glycerin, sodium chloride, sodiuim hydroxide, hexylene glycol, pyrus malus (apple) fruit extract, sodium benzoate, PEG-55 propylene glycol oleate, propylene glycol, polyquaternium-10, niacinamide, pyridoxine HCL, citric acid, linalool, limonene, saccharum officianum (sugar cane) extract, salix nigra (willow) bark extract, hexyl cinnamal, benzyl alcohol, benzyl salicylate, citrus medica limonum (lemon) peel extract, camellia sinensis leaf extract

GARNIER FRUCTIS ANTIDANDRUFF CLEAR CONTROL 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67718-963
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
APPLE (UNII: B423VGH5S9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
NIACINAMIDE (UNII: 25X51I8RD4)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SUGARCANE (UNII: 81H2R5AOH3)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LEMON PEEL (UNII: 72O054U628)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67718-963-01	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(67718-963)

Revised: 1/2020

Document Id: 5212c4f6-8e78-4b51-a54f-222418530be7

34390-5

Set id: 06ff1bc1-887b-43c9-9a27-b9f11406792d

Version: 3

Effective Time: 20200128

 

L'Oreal USA Florence Manufacturing