LEUDINE ANTI-DANDRUFF- pyrithione zinc shampoo

LEudine Anti-dandruff by

Drug Labeling and Warnings

LEudine Anti-dandruff by is a Otc medication manufactured, distributed, or labeled by B&R Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• avoid contact with 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.

Directions

• for maximum dandruff control, use every time you shampoo
• wet hair, massage onto scalp, rinse, repeat if desired
• for best results use at least twice a week or as directed by a doctor.

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

INGREDIENTS AND APPEARANCE

LEUDINE ANTI-DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76482-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76482-013-02	60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	04/01/2013

Labeler - B&R Products Inc (085560514)

Registrant - B&R Products Inc (085560514)

Establishment
Name	Address	ID/FEI	Business Operations
B&R Products Inc		085560514	MANUFACTURE(76482-013)