BIOXSINE SERIES- pyrithione zinc shampoo

Bioxsine Series by

Drug Labeling and Warnings

Bioxsine Series by is a Otc medication manufactured, distributed, or labeled by B'IOTA Laboratories, BIOTA BITKISEL ILAC VE KOZMETIK LABORATUARLARI TICARET A S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Pyrithione Zinc 1.5%

PURPOSE

Antidandruff

INDICATIONS & USAGE

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

WARNINGS

For external use only.

WHEN USING

When using this product avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

STOP USE

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

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

DOSAGE & ADMINISTRATION

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
  

STORAGE AND HANDLING

Store away from direct sunlight

INACTIVE INGREDIENT

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

QUESTIONS

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

DESCRIPTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOXSINE SERIES  
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23637-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	4.5 mL  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23637-001-01	1 in 1 CARTON
1		300 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/01/2012

Labeler - B'IOTA Laboratories (968738240)

Registrant - B'IOTA Laboratories (968738240)

Establishment
Name	Address	ID/FEI	Business Operations
BIOTA BITKISEL ILAC VE KOZMETIK LABORATUARLARI TICARET A S		566215073	manufacture