Kerastase Paris Symbiose Scalp Renewal Micro Peeling Antidandruff Treatment by L'Oreal USA Products Inc / BCM Cosmetique Drug Facts

Drug Details [pdf]

KERASTASE PARIS SYMBIOSE SCALP RENEWAL MICRO PEELING ANTIDANDRUFF TREATMENT- salicylic acid shampoo
L'Oreal USA Products Inc

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.

----------

Drug Facts

Active ingredient

Salicylic acid 1.9%

Purpose

Antidandruff

Uses

helps eliminate the symptoms of 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 of this product as directed

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
apply to hair
massage
rinse

Inactive ingredients

water, sodium laureth sulfate, sodium lauryl sulfate, glycerin, cocamide MEA, coco-betaine, laureth-5 carboxylic acid, acrylates copolymer, cocamide MIPA, sodium hydroxide, citric acid, sodium benzoate, argania spinosa shell powder, prunus armeniaca (apricot) seed powder, hexylene glycol, sodium chloride, menthol, polyquaternium-10, isopropyl myristate, PEG-55 propylene glycol oleate, propylene glycol, limonene, squalene, capryloyl salicylic acid, benzyl salicylate, benzyl alcohol, linalool, citronellol, citral, geraniol, artemisia umbelliformis flower extract,
potassium sorbate, fragrance

image of a label

KERASTASE PARIS SYMBIOSE SCALP RENEWAL MICRO PEELING ANTIDANDRUFF TREATMENT
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-463
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	19 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCO-BETAINE (UNII: 03DH2IZ3FY)
LAURETH-5 CARBOXYLIC ACID (UNII: J9933O739E)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ARGAN SHELL (UNII: 0I4NTA7UMZ)
PRUNUS ARMENIACA SEED (UNII: 75356789IW)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MENTHOL (UNII: L7T10EIP3A)
POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEG-55 PROPYLENE GLYCOL OLEATE (UNII: 7RDE7PJS40)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SQUALANE (UNII: GW89575KF9)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
CITRAL (UNII: T7EU0O9VPP)
GERANIOL (UNII: L837108USY)
ARTEMISIA UMBELLIFORMIS FLOWER (UNII: 91OLL9AJ7D)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49967-463-01	500 mL in 1 JAR; Type 0: Not a Combination Product	12/01/2022	12/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	12/01/2022	12/01/2022

Labeler - L'Oreal USA Products Inc (002136794)

Name	Address	ID/FEI	Business Operations
Establishment
BCM Cosmetique		275359578	manufacture(49967-463)

Revised: 4/2023

Document Id: 3e7e30c4-da36-4568-bce4-b65647678e6c

Set id: 5d22f4b6-2c25-453b-ac16-bfec8263a2e2

Version: 2

Effective Time: 20230417