Label: FOLREX CREAM- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64539-014-01, 64539-014-02 - Packager: Catalysis, SL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 9, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS PURPOSE
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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
- Questions or comments?
- Other Information
- Directions
- Uses
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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
- Package Label
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INGREDIENTS AND APPEARANCE
FOLREX CREAM
menthol creamProduct 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)
