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Bioxsine Series

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 4.5mL in 300mL
Labeler: B'IOTA Laboratories
NDC Code: 23637-001

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.

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

  • apply a tablespoon of shampoo to wet hair and gently massage the scalp with fingertips for 1.5 to 2 minutes and rinse well
  • for best results use at least twice a week or as directed by a doctor

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

  • Dermatologist tested
  • For women and men
  • No known side effects
  • Safe for color-treated hair
  • Revitalizes the appearance of hair and provides volume, shine and vibrancy
  • Eliminates and reduces the recurrence of the symptoms of dandruff

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

BIOXSINE SERIES  
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23637-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC4.5 mL  in 300 mL
Inactive Ingredients
Ingredient NameStrength
APIGENIN 
BENZYL ALCOHOL 
ACHILLEA MILLEFOLIUM 
CAROB 
CHAMOMILE 
EQUISETUM ARVENSE TOP 
URTICA DIOICA ROOT 
URTICA URENS LEAF 
BUTYLENE GLYCOL 
CITRIC ACID MONOHYDRATE 
.BETA.-CITRONELLOL, (R)- 
COCAMIDOPROPYL BETAINE 
GERANIOL 
GLYCERIN 
LAURETH-2 
POLIDOCANOL 
HONEY 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
OLEANOLIC ACID 
PANTHENOL 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
POLYSORBATE 20 
PROPYLENE GLYCOL 
SALICYLIC ACID 
SODIUM CHLORIDE 
SODIUM LAURETH SULFATE 
TRIDECETH-12 
VITIS VINIFERA SEED 
WATER 
Packaging
#Item CodePackage Description
1NDC:23637-001-011 BOTTLE (BOTTLE) 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/FEIOperations
BIOTA BITKISEL ILAC VE KOZMETIK LABORATUARLARI TICARET A S566215073manufacture

Revised: 12/2011
 
B'IOTA Laboratories

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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