LEUDINE ANTI-DANDRUFF- pyrithione zinc shampoo 
B&R 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.

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L'Eudine Anti-dandruff Shampoo

Active ingredient

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

for relief of flaking and itching due to dandruff, and to help prevent their recurrence.

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

Directions

Inactive ingredients

Acrylates Copolymer, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Ammonium Xylenesulfonate, Citric Acid, Cocamide MEA, Cocamidopropyl PG-Dimonium Chloride, Fragrance, Glycol Distearate, Guar Hydroxypropyltrimonium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone, Panthenol, Sodium Chloride, Triethanolamine, Water, Blue 1.

Questions?

1-800-944-5846

Package/Label Principal Display Panel

L'EUDINE

anti-dandruff Shampoo

2.0 fl. oz. (60 mL)

MADE IN USA

Bottle Label

Bottle Label

LEUDINE ANTI-DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76482-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW) (UNII: XRK36F13ZZ)  
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76482-013-0260 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H04/01/2013
Labeler - B&R Products Inc (085560514)
Registrant - B&R Products Inc (085560514)
Establishment
NameAddressID/FEIBusiness Operations
B&R Products Inc085560514MANUFACTURE(76482-013)

Revised: 2/2013
Document Id: 2deddc27-52fd-4021-bb95-36862e4dfc22
Set id: 2deddc27-52fd-4021-bb95-36862e4dfc22
Version: 1
Effective Time: 20130213
 
B&R Products Inc