FDA.reportPublic FDA data

Folrex Cream

Manufacturer
Catalysis, SL
Effective date
2018-03-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:52

Label at a glance#

ProductFolrex Cream
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

For the temporary relief of pains of minor aches and pain of muscles and joints associated with: Simple backage, strains, bruises and sprains

Dosage and administration

apply onto the affected area not more than 3 or 4 times daily Children under 4 years old, consult with a Doctor. apply onto the affected area not more than 3 or 4 times daily Children under 4 years old, consult with a Doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS PURPOSE

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%.................. External Analgesic

TubeTube

Warnings

WARNINGS SECTION

  • For external use only.
  • If conditions worsens, or if symptons persists for more than 7 days or clear up and recur within a few days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skins.
  • Do not bandaged tightly

WARNINGS

OTC - ASK DOCTOR SECTION

  • Avoid contact with eyes
  • Keep out of the reach of children. In case of overdose,get medical help or contact a Poison Control Medical 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

  • apply onto the affected area not more than 3 or 4 times daily
  • Children under 4 years old, consult with a Doctor.

DOSAGE & ADMINISTRATION SECTION

  • apply onto the affected area not more than 3 or 4 times daily
  • Children under 4 years old, consult with a Doctor.

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of pains of minor aches and pain of muscles and joints associated with:
  • Simple backage, strains, bruises and sprains

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Caprylic/Capric Triglyceride, Cetyl Alcohol, Alcohol Denat, Glycerin, Cetearyl Alcohol, Dimethicone, Menthol, Ceteth-20, Phenoxyethanol., Steareth-20, Salicylic Acid , Sodium Metabisulfite, Diazolidinyl Urea, Folic Acid, Sodium Benzoate, Potassium Sorbate, Sodium Lauryl Sulfate, Sodium Cetearyl Sulfate, Ethylhexylglycerin., Citric Acid., Parfum. Coumarin, Hexyl Cinnamal, Linalool, Limonene, Geraniol, Hydroxycitronellal

Uses

OTC - PURPOSE SECTION

For the temporary relief of pains of minor aches and pain of muscles and joints associated with:
Simple backage, strains, bruises and sprains

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138470000004650GTIN-13: 8470000004650
EAN-13: 8470000004650
GTIN storage (14 digits): 08470000004650		Caja_Folrex _crema_100ml_USA_V.5_tzd.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64539-014-022020-01-31C16284748780-19d75b9d0-069d-f424-e053-dadaa90a57ceFolrex Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-014-01Folrex Cream100 mL in 1 TUBECREAM1002
64539-014-02Folrex Cream1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-014FOLREX CREAM (MENTHOL) CREAM [CATALYSIS, SL]2Legacy NDC, 2 package rows20180309_6689c713-3731-0760-e053-2a91aa0aca30.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64539-01464539-014-01, 64539-014-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
CETETH-20I835H2IHHXIACT
STEARETH-20L0Q8IK9E08IACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM METABISULFITE4VON5FNS3CIACT
FOLIC ACID935E97BOY8IACT
COUMARINA4VZ22K1WTIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
CETYL ALCOHOL936JST6JCNIACT
LINALOOL, (-)-3U21E3V8I2IACT
LIMONENE, (+)-GFD7C86Q1WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GERANIOLL837108USYIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
ALCOHOL3K9958V90MIACT

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
6700222a-35e6-0ce2-e053-2a91aa0ab91f6689c713-3731-0760-e053-2a91aa0aca302018-03-09WarningsExact identifier
spl id: 6700222a-35e6-0ce2-e053-2a91aa0ab91f
spl set id: 6689c713-3731-0760-e053-2a91aa0aca30

Reported adverse events (FAERS/openFDA)#

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