LBEL  HOMME ANTIDANDRUFF- pyrithione zinc shampoo 
Ventura Corporation Ltd

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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LBEL HOMME
ANTIDANDRUFF SHAMPOO

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

WATER, SODIUM LAURETH SULFATE , COCAMIDE DEA, COCAMIDOPROPYL BETAINE, DIMETHICONOL, SODIUM CHLORIDE, GLYCOL DISTEARATE, 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

Puerto Rico: Distribuited by Ventura Corporation Ltd., San Juan, Puerto Rico 00924. Made in Columbia.

PRINCIPAL DISPLAY PANEL - 250 ml Bottle Label

L'BEL HOMME

Antidandruff Shampoo

> fortified hair
> daily use

L'BEL
250 ml e (8.4 fl.oz.)

Principal Display Panel - 250 ml Bottle Label
LBEL   HOMME ANTIDANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-426
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc0.00336 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-426-01250 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H01/20/2012
Labeler - Ventura Corporation Ltd (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE

Revised: 1/2012
Document Id: 9122ddf2-99a7-4150-bea1-c2acfac0a2d4
Set id: df7cfab9-d006-450b-9514-83b8a87a9d19
Version: 1
Effective Time: 20120119
 
Ventura Corporation Ltd