OILY HAIR DANDRUFF  ZERRAN INTERNATIONAL - pyrithione zinc 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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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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM C14-16 OLEFIN SULFONATE 
DISODIUM LAURETH SULFOSUCCINATE 
MAGNESIUM ALUMINUM SILICATE 
CORYMBIA CITRIODORA LEAF OIL 
ARABICA COFFEE BEAN 
PANTHENOL 
MATRICARIA RECUTITA 
ORANGE PEEL 
ACHILLEA MILLEFOLIUM 
BITTER FENNEL 
GLYCYRRHIZA GLABRA 
GINKGO 
GLYCERIN 
SORBIC ACID 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
METHYLISOTHIAZOLINONE 
SODIUM CHLORIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:38755-0111-1240 mL in 1 BOTTLENone
2NDC:38755-0111-21000 mL in 1 BOTTLENone

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/FEIOperations
Cosmetic Enterprises Ltd. 017701475manufacture

Revised: 04/2011 Zerran International Corporation