FDA.reportPublic FDA data

Bioxsine Series

Manufacturer
B'IOTA Laboratories | BIOTA BITKISEL ILAC VE KOZMETIK LABORATUARLARI TICARET A S
Effective date
2011-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:30:30

Label at a glance#

ProductBioxsine Series
Active ingredientPYRITHIONE ZINC
Label structure13 sections

Storage and handling

Store away from direct sunlight

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1.5%

OTC - PURPOSE SECTION

Antidandruff

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Store away from direct sunlight

INACTIVE INGREDIENT SECTION

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 SECTION

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

DESCRIPTION SECTION

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 CartonShampoo Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
426904zinc pyrithione 1.5 % Medicated ShampooPSN3
426904zinc pyrithione 15 MG/ML Medicated ShampooSCD3
426904zinc pyrithione 1.5 % Medicated ShampooSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23637-001-012020-01-31C16284748780-19d75b9d0-ef6b-f424-e053-dadaa90a57ce9ecacd00-cd84-4fa7-a204-bb3a3d5451f3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23637-001-01Bioxsine Series1 in 1 CARTONSHAMPOO13
23637-001-01Bioxsine Series300 mL in 1 BOTTLESHAMPOO3003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23637-001BIOXSINE SERIES (PYRITHIONE ZINC) SHAMPOO [B'IOTA LABORATORIES]3Legacy NDC, 2 package rows20120103_9ecacd00-cd84-4fa7-a204-bb3a3d5451f3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ53
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ53
.BETA.-CITRONELLOL, (R)-INACTIVE INGREDIENTP01OUT964K3
ACHILLEA MILLEFOLIUMINACTIVE INGREDIENT2FXJ6SW4PK3
APIGENININACTIVE INGREDIENT7V515PI7F63
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3
CAROBINACTIVE INGREDIENT5MG5Z946UO3
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP3
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX3
EQUISETUM ARVENSE TOPINACTIVE INGREDIENT1DP6Y6B65Z3
GERANIOLINACTIVE INGREDIENTL837108USY3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
HONEYINACTIVE INGREDIENTY9H1V576FH3
LAURETH-2INACTIVE INGREDIENTD4D38LT1L53
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN3
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA3
OLEANOLIC ACIDINACTIVE INGREDIENT6SMK8R7TGJ3
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z3
POLIDOCANOLINACTIVE INGREDIENT0AWH8BFG9A3
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8F3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V33
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X3
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP03
TRIDECETH-12INACTIVE INGREDIENTYFY3KG5Y7O3
URTICA DIOICA ROOTINACTIVE INGREDIENTJ8HE8A6E5T3
URTICA URENS LEAFINACTIVE INGREDIENT0DCW2P163M3
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXA3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23637-00123637-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
APIGENIN7V515PI7F6IACT
BENZYL ALCOHOLLKG8494WBHIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT
CAROB5MG5Z946UOIACT
CHAMOMILEFGL3685T2XIACT
EQUISETUM ARVENSE TOP1DP6Y6B65ZIACT
URTICA DIOICA ROOTJ8HE8A6E5TIACT
URTICA URENS LEAF0DCW2P163MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GERANIOLL837108USYIACT
GLYCERINPDC6A3C0OXIACT
LAURETH-2D4D38LT1L5IACT
POLIDOCANOL0AWH8BFG9AIACT
HONEYY9H1V576FHIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
OLEANOLIC ACID6SMK8R7TGJIACT
PANTHENOLWV9CM0O67ZIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
TRIDECETH-12YFY3KG5Y7OIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 473 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVENOUS0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY, METERED / NASAL5 mg/1mlExact identifier — unii candidate
50 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / OPHTHALMIC0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAMUSCULAR54 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / RECTAL129 mgExact identifier — unii candidate
50 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL11 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR144 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAMUSCULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRADERMAL7 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, EXTENDED RELEASE / ORAL335.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS18 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SPRAY / TOPICAL0.1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRASYNOVIAL4 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAVITARY0.82 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0TABLET / ORAL0.91 mgExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / RECTALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR45 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / TOPICAL0.18 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET, FILM COATED / ORAL0.35 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYSTEM / TOPICAL3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRACARDIAC1.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / EPIDURAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / ORAL1126 mgExact identifier — unii candidate
134 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ddc612b6-7001-48ed-a724-1e12f932c6189ecacd00-cd84-4fa7-a204-bb3a3d5451f32011-12-05WarningsExact identifier
spl id: ddc612b6-7001-48ed-a724-1e12f932c618
spl set id: 9ecacd00-cd84-4fa7-a204-bb3a3d5451f3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.