Label: OILY HAIR DANDRUFF ZERRAN INTERNATIONAL- zinc pyrithione cream
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Contains inactivated NDC Code(s)
NDC Code(s): 38755-0111-1, 38755-0111-2 - Packager: Zerran International Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 26, 2012
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ACTIVE INGREDIENT
Drug Facts Purpose
Zinc Pyrithione 1% Anti-Dandruff
Keep out of reach of children
-if swallowed, get medical help or contact a Poison Control Center right away.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
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INGREDIENTS AND APPEARANCE
OILY HAIR DANDRUFF ZERRAN INTERNATIONAL
zinc pyrithione creamProduct 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
