Blue Cap

Manufacturer
Catalysis, SL
Effective date
2018-09-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:51

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

Wet hair. Apply a small amount quantity of the product into hair and massage the scalp. Rinse and repeat the application. Allow the product to act for 5 minutes. Rinse throughly with enough water. For best results use at least twice a week or as directed by the doctor Wet hair. Apply a small amount quantity of the product into hair and massage the scalp. Rinse and repeat the application. Allow the product to act f...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS PURPOSE

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1%.................. Anti dandruff/ Seborrheic Dermatitis

BottleBottle

Warnings

WARNINGS SECTION

  • For external use only.
  • Avoid contact with the eyes. If contact occurs rinse the eyes throughly with water
  • If conditions worsens or does not improves 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 the Poison Control Center inmediately.

WARNINGS

OTC - ASK DOCTOR SECTION

  • For external use only.
  • Avoid contact with the eyes. If contact occurs rinse the eyes throughly with water
  • If conditions worsens or does not improves 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 the Poison Control 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

  • Wet hair. Apply a small amount quantity of the product into hair and massage the scalp. Rinse and repeat the application. Allow the product to act for 5 minutes. Rinse throughly with enough water.
  • For best results use at least twice a week or as directed by the doctor

DOSAGE & ADMINISTRATION SECTION

  • Wet hair. Apply a small amount quantity of the product into hair and massage the scalp. Rinse and repeat the application. Allow the product to act for 5 minutes. Rinse throughly with enough water.
  • 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

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Zinc Pyrithione, Alcohol Denat, Sodium Chloride, Menthol, Glycol Distearate, PEG/PPG-20/6 Dimethicone, Tocopheryl Acetate, Sodium Hydroxide, Steareth-4, Sodium Lauroyl Lactylate, Disodium EDTA, Propylene Glycol, Phenoxyethanol, Ceramide 3, Ceramide AP, Ceramide EOP, Phytosphingosine, Cholesterol, Carbomer, Xanthan Gum, Ethylhexylglycerin, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Diazolidinyl Urea, Sodium Benzoate, Potassium Sorbate, Methylchloroisothiazolinone, Methylisothiazolinone, Methylparaben, Propylparaben, Triisopropanolamine, Hexyl Cinnamal, Limonene, Benzyl Salicylate

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
64539-020-022020-01-31C16284748780-19d75b9d0-6367-f424-e053-dadaa90a57ceBlue Cap Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-020-01Blue Cap150 mL in 1 TUBESHAMPOO1502
64539-020-02Blue Cap1 in 1 BOXSHAMPOO12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-020BLUE CAP (ZINC PYRITHIONE) SHAMPOO [CATALYSIS, SL]2Legacy NDC, 2 package rows20180923_723bea65-14d4-9dd2-e053-2991aa0afae4.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64539-02064539-020-01, 64539-020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

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
75c6e8a8-5384-4bfc-e053-2991aa0af39b723bea65-14d4-9dd2-e053-2991aa0afae42018-09-13WarningsExact identifier
spl id: 75c6e8a8-5384-4bfc-e053-2991aa0af39b
spl set id: 723bea65-14d4-9dd2-e053-2991aa0afae4

Reported adverse events (FAERS/openFDA)#

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