Label: BIOXSINE SERIES- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 23637-001-01 - Packager: B'IOTA Laboratories
- 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 December 5, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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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
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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
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INGREDIENTS AND APPEARANCE
BIOXSINE SERIES
pyrithione zinc shampooProduct 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