OILY HAIR DANDRUFF  ZERRAN INTERNATIONAL- zinc pyrithione cream 
Zerran International Corporation

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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Oily Hair Dandruff Shampoo

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


Image of back label


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

8fl. oz./240 ml

Image of Front Label

OILY HAIR DANDRUFF   ZERRAN INTERNATIONAL
zinc pyrithione cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:38755-0111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:38755-0111-1240 mL in 1 BOTTLE
2NDC:38755-0111-21000 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/15/2010
Labeler - Zerran International Corporation (175106392)
Registrant - Cosmetic Enterprises Ltd. (017701475)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises Ltd. 017701475manufacture

Revised: 1/2012
Document Id: 42ba124d-14a1-4ad0-8c24-6995235cd0d6
Set id: a14b85c2-8327-455c-9c14-309eefb98aed
Version: 9
Effective Time: 20120126
 
Zerran International Corporation