Otc - Active Ingredient
Pyrithione Zinc 1.5%
Bioxsine Series
FDA Label NDC 23637-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by B'iota Laboratories for the product Bioxsine Series (NDC 23637-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.
Otc - 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
Otc - 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
Package Label.Principal Display Panel
Shampoo Carton (Shampoolabel)
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