FOLREX CREAM- menthol cream

Folrex Cream by

Drug Labeling and Warnings

Folrex Cream by is a Otc medication manufactured, distributed, or labeled by Catalysis, SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

FOLREX CREAM 
menthol cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	0.3 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.1 mg  in 1 mL
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)	10 mg  in 1 mL
CETETH-20 (UNII: I835H2IHHX)	1.221 mg  in 1 mL
STEARETH-20 (UNII: L0Q8IK9E08)	0.521 mg  in 1 mL
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	0.09 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	3 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O)	1.5 mg  in 1 mL
SALICYLIC ACID (UNII: O414PZ4LPZ)	0.5 mg  in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	0.3 mg  in 1 mL
FOLIC ACID (UNII: 935E97BOY8)	0.114 mg  in 1 mL
COUMARIN (UNII: A4VZ22K1WT)	0.1 mg  in 1 mL
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)	0.1 mg  in 1 mL
CETYL ALCOHOL (UNII: 936JST6JCN)	5.257 mg  in 1 mL
LINALOOL, (-)- (UNII: 3U21E3V8I2)	0.1 mg  in 1 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.1 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.72 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.08 mg  in 1 mL
GERANIOL (UNII: L837108USY)	0.1 mg  in 1 mL
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)	0.1 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.1 mg  in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.08 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	100 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M)	5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64539-014-02	1 in 1 BOX	03/03/2018
1	NDC: 64539-014-01	100 mL in 1 TUBE; Type 0: Not a Combination Product

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	Business Operations
Catalysis, SL		862795119	manufacture(64539-014)