OILY HAIR DANDRUFF ZERRAN INTERNATIONAL- zinc pyrithione cream

Oily Hair Dandruff by

Drug Labeling and Warnings

Oily Hair Dandruff by is a Otc medication manufactured, distributed, or labeled by Zerran International Corporation, Cosmetic Enterprises Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts                               Purpose

Zinc Pyrithione 1%              Anti-Dandruff

helps prevent flaking and itching associated with dandruff

Keep out of reach of children
-if swallowed, get medical help or contact a Poison Control Center right away.

-for external use only

When using this product
-avoid contact with eyes. If contact occurs rinse thoroughly with water

Stop use and ask a doctor if
-condition worsens or does not improve after regular use of this product as directed

-For best results use every time you shampoo.

-Wet hair, apply shampoo, then rinse.

-For best results apply at least twice a week

Inactive Ingredients: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Lauryl Dimethylamie Oxide, Magnesium Aluminum Silicate, Hydrolyzed Soy Protein, Camellia Sinensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eucalyptus Globulus Leaf Oil, Coffea Arabica (Coffee) Seed Extract, Panthenol, Oat Amino Acids, Extracts of: Chamomilla Recutita (Matricaria) Flower, Citrus Aurantium Dulcis (Orange) Peel, Althea Officinalis, Achillea Millefolium, Foeniculum Vulgare (Fennel) Fruit, Glycyrrhiza Glabra (Licorice) Root, Ginkgo Biloba Leaf, Glycerin, Sorbic Acid, Citric Acid, Disodium EDTA, Methylisothiazolinone, Sodium Chloride, Blue 1, Yellow 5

PRINCIPAL DISPLAY PANEL

Zerran Hair Care
Oily Hair Dandruff Shampoo
33.81 fl.oz./1 Liter

8fl. oz./240 ml

INGREDIENTS AND APPEARANCE

OILY HAIR DANDRUFF   ZERRAN INTERNATIONAL
zinc pyrithione cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 38755-0111
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 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
PANTHENOL (UNII: WV9CM0O67Z)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
ORANGE PEEL (UNII: TI9T76XD44)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
BITTER FENNEL (UNII: J5W36Y5WG8)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GINKGO (UNII: 19FUJ2C58T)
GLYCERIN (UNII: PDC6A3C0OX)
SORBIC ACID (UNII: X045WJ989B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 38755-0111-1	240 mL in 1 BOTTLE
2	NDC: 38755-0111-2	1000 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/15/2010

Labeler - Zerran International Corporation (175106392)

Registrant - Cosmetic Enterprises Ltd. (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd.		017701475	manufacture