KERASTASE PARIS K SYMBIOSE SCALP RENEWAL MICRO EXFOLIATING SCRUB ANTIDANDRUFF TREATMENT- salicylic acid shampoo

Kerastase Paris K Symbiose Scalp Renewal Micro Exfoliating Scrub Antidandruff Treatment by

Drug Labeling and Warnings

Kerastase Paris K Symbiose Scalp Renewal Micro Exfoliating Scrub Antidandruff Treatment by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, BCM Cosmetique. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KERASTASE PARIS K SYMBIOSE SCALP RENEWAL MICRO EXFOLIATING SCRUB ANTIDANDRUFF TREATMENT 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-136
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-136-01	500 mL in 1 JAR; Type 0: Not a Combination Product	12/01/2022	12/01/2024
2	NDC: 49967-136-02	200 mL in 1 TUBE; Type 0: Not a Combination Product	05/02/2023	04/09/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	12/01/2022	04/09/2025

Labeler - L'Oreal USA Products Inc. (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
BCM Cosmetique		275359578	manufacture(49967-136)

Establishment
Name	Address	ID/FEI	Business Operations
PRODUCTOS CAPILARES LOREAL SA		633333356	manufacture(49967-136)