Active Ingredients Purpose
Menthol 1.25%.................. External Analgesic
Folrex Cream
FDA Label NDC 64539-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Catalysis, Sl for the product Folrex Cream (NDC 64539-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients purpose, warnings, questions or comments?, other information, directions, dosage & administration, uses, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
- 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
- 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
Keep out of reach of children
Questions Or Comments?
+ 34 91 345 6902 M-F 9:00 am to 5:00 pm
Other Information
. keep the product in a cool and dry place
Directions
- apply onto the affected area not more than 3 or 4 times daily
- Children under 4 years old, consult with a Doctor.
Dosage & Administration
- apply onto the affected area not more than 3 or 4 times daily
- Children under 4 years old, consult with a Doctor.
Uses
- For the temporary relief of pains of minor aches and pain of muscles and joints associated with:
- Simple backage, strains, bruises and sprains
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
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
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