Folrex Cream

Dosage form: cream
Ingredients: MENTHOL 1.25mg in 1mL
Labeler: Catalysis, SL
NDC code: 64539-014

Medically reviewed by Drugs.com. Last updated on Feb 27, 2025.

Folrex Cream

ACTIVE INGREDIENTS PURPOSE

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

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

WARNINGS

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

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.

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

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

Uses

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

FOLREX CREAM
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64539-014
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	1.25 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIAZOLIDINYL UREA	0.3 mg in 1 mL
POTASSIUM SORBATE	0.1 mg in 1 mL
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE	10 mg in 1 mL
CETETH-20	1.221 mg in 1 mL
STEARETH-20	0.521 mg in 1 mL
SODIUM LAURYL SULFATE	0.09 mg in 1 mL
GLYCERIN	3 mg in 1 mL
DIMETHICONE	1.5 mg in 1 mL
SALICYLIC ACID	0.5 mg in 1 mL
SODIUM METABISULFITE (BISULFITE ION)	0.3 mg in 1 mL
FOLIC ACID	0.114 mg in 1 mL
COUMARIN	0.1 mg in 1 mL
.ALPHA.-HEXYLCINNAMALDEHYDE	0.1 mg in 1 mL
CETYL ALCOHOL	5.257 mg in 1 mL
LINALOOL, (-)-	0.1 mg in 1 mL
LIMONENE, (+)-	0.1 mg in 1 mL
PHENOXYETHANOL	0.72 mg in 1 mL
ETHYLHEXYLGLYCERIN	0.08 mg in 1 mL
GERANIOL	0.1 mg in 1 mL
HYDROXYCITRONELLAL	0.1 mg in 1 mL
SODIUM BENZOATE	0.1 mg in 1 mL
CITRIC ACID MONOHYDRATE	0.08 mg in 1 mL
WATER	100 mg in 1 mL
ALCOHOL	5 mg in 1 mL

Packaging
#	Item Code	Package Description
1	NDC:64539-014-02	1 TUBE in 1 BOX
1	NDC:64539-014-01	100 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/03/2018

Labeler - Catalysis, SL (862795119)

Registrant - Catalysis, SL (862795119)

Establishment
Name	Address	ID/FEI	Operations
Catalysis, SL		862795119	manufacture(64539-014)

Revised: 03/2018

Document Id: 6700222a-35e6-0ce2-e053-2a91aa0ab91f

Set id: 6689c713-3731-0760-e053-2a91aa0aca30

Version: 2

Effective Time: 20180309

Catalysis, SL

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Folrex Cream

Further information

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