Label: MENTHOL cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50488-1040-1 - Packager: Alexso, Inc
- 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 April 24, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
When using this product
- Avoid contact with the eyes
- Do not use in large quantities, particularly over raw surfaces or blistered areas
- Do not apply to wounds or damaged skin
- Do not bandage
Stop use and ask a doctor if
- allergic reaction occurs
- condition worsens or does not improve within 7 days
- symptoms clear up and return within a few days
- redness, irritation, swelling, pain or other symptoms begin or increase
- Avoid contact with the eyes
- Other information
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Inactive ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Alcohol, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine
Menthol 4% Cream
NDC: 50488-1040-1
120 grams
Manufactured for:
Alexso, Inc
Los Angeles, CA 90064 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MENTHOL
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-1040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 40 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1) LAURETH-7 (UNII: Z95S6G8201) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50488-1040-1 120 g in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 04/01/2019 Labeler - Alexso, Inc (963338061)