FOLREX CREAM- menthol cream 
Catalysis, SL

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Folrex Cream

ACTIVE INGREDIENTS PURPOSE

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

Tube

Warnings

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.

Uses

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

Box

FOLREX CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64539-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64539-014-021 in 1 BOX03/03/2018
1NDC:64539-014-01100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/03/2018
Labeler - Catalysis, SL (862795119)
Registrant - Catalysis, SL (862795119)
Establishment
NameAddressID/FEIBusiness Operations
Catalysis, SL862795119manufacture(64539-014)

Revised: 3/2018
Document Id: 6700222a-35e6-0ce2-e053-2a91aa0ab91f
Set id: 6689c713-3731-0760-e053-2a91aa0aca30
Version: 2
Effective Time: 20180309
 
Catalysis, SL