BIOXSINE SERIES  - pyrithione zinc shampoo 
B'IOTA Laboratories

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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Pyrithione Zinc 1.5%

Antidandruff

Helps eliminate and reduces the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff.

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 as directed.

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

Directions

Store away from direct sunlight

Cosmetic Ingredients Acrylates Copolymer, Amodimethicone, Apigenin, Benzyl Alcohol, Biocomplex B11 Herbal Extract [Achillea Millefolium Extract], Ceratonia Siliqua (Carob) Fruit Extract, Chamomilla Recutita (Matricaria) Flower Extract, Equisetum Arvense Extract, Urtica Dioica (Nettle) Root Extract, Urtica Urens Leaf Extract, Biotinoyl Tripeptide-1, Butylene Glycol, C11-15 Pareth-7, Citric Acid, Citronellol, Cocamidopropyl Betaine, Fragrance, Geraniol, Glycerin, Hydroxypropyl Guar Hydroxyproplytrimonium Chloride, Laureth-2, Laureth-9, Mel, Methylchloroisothiazolinone, Methylisothiazolinole, Oleanolic Acid, Panthenol, PEG-40 Hydrogenated Castor Oil, PEG/PPG-120/10 Trimethylpropane Trioleate, Polysorbate 20, PPG-26-Buteth-26, Propylene Glycol, Salicylic Acid, Sodium Chloride, Sodium Laureth Sulfate, Trideceth-12, Vitis Vinifera (Grape) Seed Extract, Water


Toll Free 1-855-246-8291 Monday through Friday, 9am-5pm

B'IOTA Botanicals Dandruff Shampoo

Benefits


Distributed by:
B'IOTA Botanical Laboratories
2 Greenwich Office Park, Suite 300
Greenwich, CT 06830

Product of Turkey

www.biotabotanicals.com
Toll Free 855-246-8291

Shampoo Carton

BIOXSINE SERIES  
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23637-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC4.5 mL  in 300 mL
Inactive Ingredients
Ingredient NameStrength
APIGENIN (UNII: 7V515PI7F6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
CAROB (UNII: 5MG5Z946UO)  
CHAMOMILE (UNII: FGL3685T2X)  
EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)  
URTICA DIOICA ROOT (UNII: J8HE8A6E5T)  
URTICA URENS LEAF (UNII: 0DCW2P163M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GERANIOL (UNII: L837108USY)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURETH-2 (UNII: D4D38LT1L5)  
POLIDOCANOL (UNII: 0AWH8BFG9A)  
HONEY (UNII: Y9H1V576FH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
PANTHENOL (UNII: WV9CM0O67Z)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
TRIDECETH-12 (UNII: YFY3KG5Y7O)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23637-001-011 in 1 CARTON
1300 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/01/2012
Labeler - B'IOTA Laboratories (968738240)
Registrant - B'IOTA Laboratories (968738240)
Establishment
NameAddressID/FEIBusiness Operations
BIOTA BITKISEL ILAC VE KOZMETIK LABORATUARLARI TICARET A S566215073manufacture

Revised: 12/2011
Document Id: ddc612b6-7001-48ed-a724-1e12f932c618
Set id: 9ecacd00-cd84-4fa7-a204-bb3a3d5451f3
Version: 3
Effective Time: 20111205
 
B'IOTA Laboratories