FDA.reportPublic FDA data

Blue Cap Spray

Manufacturer
Catalysis, SL
Effective date
2018-09-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:56:47

Label at a glance#

ProductBlue Cap
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Indications and uses

For the relief of the symptons of dandruff and seborrheic dermatitis

Dosage and administration

Shake well before use. To be use in upright position. Apply 2-3 times a day to any affected area. For best results use at least twice a week or as directed by the doctor Shake well before use. To be use in upright position. Apply 2-3 times a day to any affected area. For best results use at least twice a week or as directed by the doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS PURPOSE

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 0.19%.................. Antidandruff/ Seborrheic Dermatitis

TubeTube

Warnings

WARNINGS SECTION

  • For external use only.
  • Avoid contact with the eyes. If contact occurs, rinse throughly with water
  • If conditions worsens or does not improve after regular use of this product as directed, consult with a doctor
  • When using this product KEEP out of the reach of children. In case of overdose get medical help or contact a Poison Center inmediately

WARNINGS

OTC - ASK DOCTOR SECTION

  • For external use only.
  • Avoid contact with the eyes. If contact occurs, rinse throughly with water
  • If conditions worsens or does not improve after regular use of this product as directed, consult with a doctor
  • When using this product KEEP out of the reach of children. In case of overdose get medical help or contact a Poison Center inmediately

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Questions or comments?

OTC - QUESTIONS SECTION

+ 34 91 345 6902 M-F 9:00 am to 5:00 pm

Other Information

OTHER SAFETY INFORMATION

. keep the product in a cool and dry place

Directions

INSTRUCTIONS FOR USE SECTION

  • Shake well before use. To be use in upright position. Apply 2-3 times a day to any affected area.
  • For best results use at least twice a week or as directed by the doctor

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use. To be use in upright position. Apply 2-3 times a day to any affected area.
  • For best results use at least twice a week or as directed by the doctor

Uses

INDICATIONS & USAGE SECTION

  • For the relief of the symptons of dandruff and seborrheic dermatitis

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Isopropyl Myristate, Alcohol, Isobutane, Propane. Bisabolol, Polysorbate 80, Zinc Pyrithione, Butane, Tocopheryl Acetate, Farnesol

Uses

OTC - PURPOSE SECTION

  • For the relief of the symptons of dandruff and seborrheic dermatitis

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64539-021-022020-01-31C16284748780-19d75b9d0-b5d8-f424-e053-dadaa90a57ceBlue Cap Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-021-01Blue Cap100 mL in 1 TUBESPRAY1003
64539-021-02Blue Cap1 in 1 BOXSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-021BLUE CAP (ZINC PYRITHIONE) SPRAY [CATALYSIS, SL]3Legacy NDC, 2 package rows20180914_7253bb24-701b-0a38-e053-2991aa0a8037.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64539-02164539-021-01, 64539-021-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
FARNESOLEB41QIU6JLIACT
PROPANET75W9911L6IACT
ISOBUTANEBXR49TP611IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LEVOMENOL24WE03BX2TIACT
BUTANE6LV4FOR43RIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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
75c6adb9-87db-9164-e053-2a91aa0a30477253bb24-701b-0a38-e053-2991aa0a80372018-09-13WarningsExact identifier
spl id: 75c6adb9-87db-9164-e053-2a91aa0a3047
spl set id: 7253bb24-701b-0a38-e053-2991aa0a8037

Reported adverse events (FAERS/openFDA)#

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