LBEL HOMME ANTIDANDRUFF- pyrithione zinc shampoo

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Ventura International Ltd, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

ZINC PYRITHIONE 0.336 %

Purpose

Antidandruff shampoo

Uses

Reduces the symptoms of dandruff

Warnings

For external use only

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

If condition worsens or does not improve after regular use of this product as directed, consult a doctor

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.

Inactive ingredients

AQUA (WATER), SODIUM LAURETH SULFATE , COCAMIDE DEA, COCAMIDOPROPYL BETAINE, DIMETHICONOL, SODIUM CHLORIDE, GLYCOL DISTEARATE, PARFUM (FRAGRANCE), GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE, BUTYLENE GLYCOL, HYDROXYPROPYL METHYLCELLULOSE, COCO-GLUCOSIDE, TEA-DODECYLBENZENESULFONATE, HYDROLYZED SOY PROTEIN, HYDROLYZED WHEAT PROTEIN, GLYCERYL STEARATE, GLYCERYL OLEATE, MAGNESIUM NITRATE, MENTHYL PCA, ZINC CHLORIDE, GLYCERIN, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL, MENTHOL, DIPROPYLENE GLYCOL, METHYLCHLOROISOTHIAZOLINONE, MAGNESIUM CHLORIDE, METHYLISOTHIAZOLINONE, APIGENIN, OLEANOLIC ACID, MORINGA PTERYGOSPERMA SEED EXTRACT, BIOTINOYL TRIPEPTIDE-1

SPL UNCLASSIFIED SECTION

US: Distributed by Ventura International Ltd. San Francisco, CA 94111. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 250 ml Bottle

L'BEL HOMME

Antidandruff Shampoo

> fortified hair

> daily use

L'BEL

250 ml e (8.4 fl.oz.)

INGREDIENTS AND APPEARANCE

LBEL   HOMME ANTIDANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-436
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	0.00336 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium Laureth Sulfate (UNII: BPV390UAP0)
Coco Diethanolamide (UNII: 92005F972D)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
Trolamine (UNII: 9O3K93S3TK)
Butylene Glycol (UNII: 3XUS85K0RA)
Coco Glucoside (UNII: ICS790225B)
Tea-dodecylbenzenesulfonate (UNII: 8HM7ZD48HN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Magnesium Nitrate (UNII: 77CBG3UN78)
Menthyl Pyrrolidone Carboxylate, (-),Dl- (UNII: 8P18J856U2)
Zinc Chloride (UNII: 86Q357L16B)
Glycerin (UNII: PDC6A3C0OX)
Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)
Menthol (UNII: L7T10EIP3A)
Dipropylene Glycol (UNII: E107L85C40)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Magnesium Chloride (UNII: 02F3473H9O)
Methylisothiazolinone (UNII: 229D0E1QFA)
Apigenin (UNII: 7V515PI7F6)
Oleanolic Acid (UNII: 6SMK8R7TGJ)
Moringa Oleifera Seed (UNII: TIX5482832)
Biotinoyl Tripeptide-1 (UNII: O6380721VA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-436-01	250 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	01/20/2012

Labeler - Ventura International Ltd (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE