FDA.reportPublic FDA data

Blue Cap Cream

Manufacturer
Catalysis, SL
Effective date
2018-07-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:28

Label at a glance#

ProductBlue Cap Cream
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Indications and uses

For the relief of the symptons of seborrheic dermatitis

Dosage and administration

apply twice a day on affected area. for best results use at least twice a week or as directed by the doctor apply twice a day on 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 0.2%.................. Seborrheic Dermatitis

TubeTube

Warnings

WARNINGS SECTION

  • For external use only.
  • Stop use and ask a doctor if rash occurs.
  • Do not use on damaged or broken skin
  • KEEP out of the reach of children

WARNINGS

OTC - ASK DOCTOR SECTION

  • For external use only.
  • Stop use and ask a doctor if rash occurs.
  • Do not use on damaged or broken skin
  • KEEP out of the reach of children

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

  • apply twice a day on affected area.
  • for best results use at least twice a week or as directed by the doctor

DOSAGE & ADMINISTRATION SECTION

  • apply twice a day on 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 seborrheic dermatitis

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Isopropyl Palmitate, Diethylhexyl Carbonate, Sucrose Cocoate, Polyglyceryl-3 Methylglucose Distearate, Glycerin, Cyclopentasiloxane, Glyceryl Stearate. Zinc Pyrithione. Tocopheryl Acetate, Stearyl Alcohol, Methyl Gluceth-20, BHT, BHA, Propylene Glycol, Bisabolol, Carbomer, Sodium Lauroyl Lactylate, Ceramide 3, Ceramide AP, Ceramide EOP, Phytosphingosine, Cholesterol, Xanthan Gum, Diazolidinyl Urea, Sodium Methylparaben, Sodium Propylparaben, Farnesol, Citric Acid, Methylparaben, Propylparaben, Phosphoric Acid, Parfum

Uses

OTC - PURPOSE SECTION

  • For the relief of the symptons of seborrheic dermatitis

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64539-019-022020-01-31C16284748780-19d75b9d0-ba97-f424-e053-dadaa90a57ceBlue Cap Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-019-01Blue Cap Cream56 mL in 1 TUBECREAM561
64539-019-02Blue Cap Cream1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-019BLUE CAP CREAM (ZINC PYRITHIONE) CREAM [CATALYSIS, SL]1Legacy NDC, 2 package rows20180730_722baecb-08d5-0763-e053-2991aa0a8a9b.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64539-01964539-019-01, 64539-019-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
CERAMIDE APF1X8L2B00JIACT
WATER059QF0KO0RIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
DIETHYLHEXYL CARBONATEYCD50O0Z6LIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
GLYCERINPDC6A3C0OXIACT
SUCROSE COCOATE3H18P0UK73IACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
STEARYL ALCOHOL2KR89I4H1YIACT
METHYL GLUCETH-20J3QD0LD11PIACT
LINALOOL, (-)-3U21E3V8I2IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
PROPANEDIOL5965N8W85TIACT
GERANIOLL837108USYIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
LEVOMENOL24WE03BX2TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CERAMIDE 34370DF050BIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
CERAMIDE 15THT33P7X7IACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CHOLESTEROL97C5T2UQ7JIACT
XANTHAN GUMTTV12P4NEEIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
FARNESOLEB41QIU6JLIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PHOSPHORIC ACIDE4GA8884NNIACT
.BETA.-CITRONELLOL, (S)-8RSY5Y5658IACT
BENZYL SALICYLATEWAO5MNK9TUIACT
COUMARINA4VZ22K1WTIACT
BENZYL BENZOATEN863NB338GIACT

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
722baecb-08d4-0763-e053-2991aa0a8a9b722baecb-08d5-0763-e053-2991aa0a8a9b2018-07-29WarningsExact identifier
spl id: 722baecb-08d4-0763-e053-2991aa0a8a9b
spl set id: 722baecb-08d5-0763-e053-2991aa0a8a9b

Reported adverse events (FAERS/openFDA)#

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