MATRIX BIOLAGE RAW ANTIDANDRUFF- salicylic acid shampoo

Matrix Biolage Raw Antidandruff by

Drug Labeling and Warnings

Matrix Biolage Raw Antidandruff by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA, INC, Unette Corporation, Universal Packaging Systems Inc. (DBA: PakLab). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 2.9%

Purpose

Antidandruff

Uses

• controls the symptoms of dandruff
• helps stop the recurrence of scalp itching, irritation, redness, flaking, and scaling associated with dandruff

Warnings

For external use only

Do not use

on children under 2 years of age, unless directed by a doctor

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 
• apply to wet hair by gently massaging onto scalp and hair
• rinse
• repeat
• allow to sit on scalp for 1-2 minutes
• rinse

Inactive ingredients

water, lauroyl/myristoyl methyl glucamide, decyl glucoside, coco-betaine, sodium cocoyl isethionate, sodium chloride, sodium hydroxide, glycerin, cocamide MIPA, citric acid, brassicamidopropyl dimethylamine, hydrogenated coconut acid, sorbic acid, sodium isethionate, salix alba bark extract willow bark extract, sodium phytate, rosmarinus officinalis leaf extract / rosemary leaf extract, alcohol, sodium benzoate, lactic acid, potassium sorbate

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MATRIX BIOLAGE RAW ANTIDANDRUFF 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-271
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	29 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAUROYL/MYRISTOYL METHYL GLUCAMIDE (UNII: SC667B999P)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
COCO-BETAINE (UNII: 03DH2IZ3FY)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
sodium hydroxide (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBIC ACID (UNII: X045WJ989B)
SODIUM ISETHIONATE (UNII: 3R36J71C17)
ALCOHOL (UNII: 3K9958V90M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LACTIC ACID (UNII: 33X04XA5AT)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
PHYTATE SODIUM (UNII: 88496G1ERL)
SALIX ALBA BARK (UNII: 205MXS71H7)
ROSEMARY (UNII: IJ67X351P9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-271-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2018
2	NDC: 49967-271-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2018
3	NDC: 49967-271-03	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2018
4	NDC: 49967-271-04	10 mL in 1 PACKET; Type 0: Not a Combination Product	09/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/01/2018

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC		960317444	manufacture(49967-271)

Establishment
Name	Address	ID/FEI	Business Operations
Unette Corporation		011401882	pack(49967-271)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems Inc. (DBA: PakLab)		078717086	pack(49967-271)