FDA.reportPublic FDA data

Biotin H3 Anti-Dandruff Normal

Manufacturer
Salones de Belleza y Equipos de El Salvador Sociedad Anonima de Capital Variable
Effective date
2021-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:57

Label at a glance#

ProductBiotin H3 Anti-Dandruff Normal
Active ingredientPYRITHIONE ZINC
Label structure7 sections

Indications and uses

Controls and helps eliminate the symptoms of dandruff asoiciated with itching irritation redness flaking

Dosage and administration

wet hair, massage BIOTIN H3 Shampoo onto scalp, rinse, repeat if desired • for best results use at least twice a week or as directed by a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Pyrithione Zinc 1% ……………………………………….Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

Controls and helps eliminate the symptoms of dandruff asoiciated with

  • itching
  • irritation
  • redness
  • flaking

Warnings

WARNINGS SECTION

For external uses only. Avoid contact with the eyes. If conctact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens or does not improve after regular use of this product.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

wet hair, massage BIOTIN H3 Shampoo onto scalp, rinse, repeat if desired • for best results use at least twice a week or as directed by a doctor

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Acrylates Copolymer, Cocamide MEA, Dimethiconol (and) TEA-Dodecylbenzenesulfonate, Glycerin, Tetrasodium EDTA, DMDM Hydantoin (and) Methylchloroisothiazolinone (and) Methylisothiazolinone, Citric Acid, PEG-120 Methyl Glucose Dioleate, Fragrance, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Polyquaternium -7

Questions or comments?

OTC - QUESTIONS SECTION

+1-302-628-4178 (M-F) 8 AM-5PM EST or www.sabesa.com.sv

Prinicipal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New/Nuevo

Biotin H3

UltraZinc

Anti-Dandruff/Control Caspa

Pyrithione Zinc 1%

12 oz (355 mL)

Normal Hair/Cabello Normal

Normal hairNormal hair

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN2
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD2
209884zinc pyrithione 1 % Medicated ConditionerSY2
209884zinc pyrithione 1 % Medicated ShampooSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73388-102-122021-07-23C16284748780-1c7ccaba7-1599-fd44-e053-dadaa90aa01bBiotin H3 Anti-Dandruff Shampoo Normal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73388-102-12Biotin H3 Anti-Dandruff Normal355 mL in 1 BOTTLE, PLASTICSHAMPOO3552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73388-102BIOTIN H3 ANTI-DANDRUFF NORMAL (PYRITHIONE ZINC) SHAMPOO [SALONES DE BELLEZA Y EQUIPOS DE EL SALVADOR SOCIEDAD ANONIMA DE CAPITAL VARIABLE]2Legacy NDC, 1 package rows20210115_9aefb755-269e-1d8b-e053-2a95a90a1df7.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73388-10273388-102-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM LAUROYL SARCOSINATE632GS99618IACT
COCO MONOETHANOLAMIDEC80684146DIACT
DIMETHICONOL (100000 CST)OSA9UP217SIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
TRIETHANOLAMINE DODECYLBENZENESULFONATE8HM7ZD48HNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DMDM HYDANTOINBYR0546TOWIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
EDETATE SODIUMMP1J8420LUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

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
b8e95b54-e431-11e7-e053-2995a90a57ce9aefb755-269e-1d8b-e053-2a95a90a1df72021-01-14WarningsExact identifier
spl id: b8e95b54-e431-11e7-e053-2995a90a57ce
spl set id: 9aefb755-269e-1d8b-e053-2a95a90a1df7

Reported adverse events (FAERS/openFDA)#

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