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NDC 50488-6641-01 Lidocaine and Menthol 4.8; 1.2 g/120g; g/120g Details
Lidocaine and Menthol 4.8; 1.2 g/120g; g/120g
Lidocaine and Menthol is a ORAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc. The primary component is LIDOCAINE; MENTHOL.
Product Information
| NDC | 50488-6641 |
|---|---|
| Product ID | 50488-6641_cc43a756-6e26-4228-8f0e-4d3ab7979f76 |
| Associated GPIs | 90859902884040 |
| GCN Sequence Number | 082316 |
| GCN Sequence Number Description | lidocaine/menthol GEL (GRAM) 4 %-1 % TOPICAL |
| HIC3 | Q5H |
| HIC3 Description | TOPICAL LOCAL ANESTHETICS |
| GCN | 49698 |
| HICL Sequence Number | 007837 |
| HICL Sequence Number Description | LIDOCAINE/MENTHOL |
| Brand/Generic | Generic |
| Proprietary Name | Lidocaine and Menthol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lidocaine, Menthol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | ORAL |
| Active Ingredient Strength | 4.8; 1.2 |
| Active Ingredient Units | g/120g; g/120g |
| Substance Name | LIDOCAINE; MENTHOL |
| Labeler Name | Alexso, Inc |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 50488-6641-01 (50488664101)
| NDC Package Code | 50488-6641-1 |
|---|---|
| Billing NDC | 50488664101 |
| Package | 120 g in 1 TUBE (50488-6641-1) |
| Marketing Start Date | 2021-02-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6dbfccb2-332b-4d45-bacf-0b539420e2f7 Details
SPL UNCLASSIFIED SECTION
LIDOCAINE AND MENTHOL - Lidocaine 4% and Menthol 1% Gel
Alexso, Inc
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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Lidocaine 4% and Menthol 1% Gel
Drug Facts
Uses
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
Directions
Other information
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
INGREDIENTS AND APPEARANCE
| LIDOCAINE AND MENTHOL
lidocaine, menthol gel |
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| Labeler - Alexso, Inc (963338061) |