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NDC 50488-6541-01 Lidocaine 4 Percent and Menthol 1 Percent Roll-On 2; .5 g/50mL; g/50mL Details
Lidocaine 4 Percent and Menthol 1 Percent Roll-On 2; .5 g/50mL; g/50mL
Lidocaine 4 Percent and Menthol 1 Percent Roll-On is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Alexso, Inc. The primary component is LIDOCAINE HYDROCHLORIDE; MENTHOL.
Product Information
| NDC | 50488-6541 |
|---|---|
| Product ID | 50488-6541_e2dc4651-36ef-4bc9-b427-718e53292dbc |
| Associated GPIs | 90859902880920 |
| GCN Sequence Number | 082348 |
| GCN Sequence Number Description | lidocaine/menthol LIQD ROLON 4 %-1 % TOPICAL |
| HIC3 | Q5H |
| HIC3 Description | TOPICAL LOCAL ANESTHETICS |
| GCN | 49741 |
| HICL Sequence Number | 007837 |
| HICL Sequence Number Description | LIDOCAINE/MENTHOL |
| Brand/Generic | Generic |
| Proprietary Name | Lidocaine 4 Percent and Menthol 1 Percent Roll-On |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lidocaine and Menthol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | TOPICAL |
| Active Ingredient Strength | 2; .5 |
| Active Ingredient Units | g/50mL; g/50mL |
| Substance Name | LIDOCAINE HYDROCHLORIDE; 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 50488-6541-01 (50488654101)
| NDC Package Code | 50488-6541-1 |
|---|---|
| Billing NDC | 50488654101 |
| Package | 50 mL in 1 BOTTLE, WITH APPLICATOR (50488-6541-1) |
| Marketing Start Date | 2021-02-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 511ee92e-f69c-4d21-aadd-84a06aca00c2 Details
SPL UNCLASSIFIED SECTION
LIDOCAINE AND MENTHOL - Lidocaine 4% and Menthol 1% Roll-On
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% Roll-On
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
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| LIDOCAINE 4 PERCENT AND MENTHOL 1 PERCENT ROLL-ON
lidocaine and menthol liquid |
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| Labeler - Alexso, Inc (963338061) |
Revised: 2/2021
Document Id: e2dc4651-36ef-4bc9-b427-718e53292dbc
Set id: 511ee92e-f69c-4d21-aadd-84a06aca00c2
Version: 2
Effective Time: 20210223