Label: LIDOCAINE AND MENTHOL- lidocaine, menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50488-6641-1 - 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 February 17, 2021
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SPL UNCLASSIFIED SECTION
LIDOCAINE AND MENTHOL - Lidocaine 4% and Menthol 1% Gel
Alexso, IncDisclaimer: 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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Lidocaine 4% and Menthol 1% Gel
Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
When using this product
- do not use in or near 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
- do not use in or near the eyes
- Directions
- Other information
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Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Glucosamine Sulfate, Ilex Paraguariensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Triethanolamine, Zemea (Corn) Propanediol
Lidocaine 4% and Menthol 1% Gel
NDC 50488-6641-1
120 grams
Manufactured for:
Alexso, Inc.
Los Angeles, CA 90064 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIDOCAINE AND MENTHOL
lidocaine, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-6641 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4.8 g in 120 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.2 g in 120 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) TROLAMINE (UNII: 9O3K93S3TK) CORN (UNII: 0N8672707O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50488-6641-1 120 g in 1 TUBE; Type 0: Not a Combination Product 02/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 02/17/2021 Labeler - Alexso, Inc (963338061)