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NDC 50488-6263-01 Lidocaine 4 Percent PLUS 4 g/100g Details
Lidocaine 4 Percent PLUS 4 g/100g
Lidocaine 4 Percent PLUS is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc.. The primary component is LIDOCAINE.
Product Information
| NDC | 50488-6263 |
|---|---|
| Product ID | 50488-6263_c462c364-268f-4f29-b846-4524d529d391 |
| Associated GPIs | 90850060103735 |
| GCN Sequence Number | 075061 |
| GCN Sequence Number Description | lidocaine HCl CREAM (G) 4 % TOPICAL |
| HIC3 | Q5H |
| HIC3 Description | TOPICAL LOCAL ANESTHETICS |
| GCN | 39982 |
| HICL Sequence Number | 001478 |
| HICL Sequence Number Description | LIDOCAINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Lidocaine 4 Percent PLUS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lidocaine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | g/100g |
| Substance Name | LIDOCAINE |
| 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 50488-6263-01 (50488626301)
| NDC Package Code | 50488-6263-1 |
|---|---|
| Billing NDC | 50488626301 |
| Package | 1 TUBE in 1 CARTON (50488-6263-1) / 120 g in 1 TUBE |
| Marketing Start Date | 2018-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 75eca17e-af14-416e-bb24-5b94c1e68291 Details
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
Directions
Other Information
Inactive ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, Magnesium Sulfate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| LIDOCAINE 4 PERCENT PLUS
lidocaine cream |
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| Labeler - Alexso, Inc. (963338061) |
Revised: 2/2019
Document Id: c462c364-268f-4f29-b846-4524d529d391
Set id: 75eca17e-af14-416e-bb24-5b94c1e68291
Version: 2
Effective Time: 20190212