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NDC 73564-0800-02 Lidonex 4 g/100mL Details
Lidonex 4 g/100mL
Lidonex is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Newpharma, Inc.. The primary component is LIDOCAINE HYDROCHLORIDE.
Product Information
NDC | 73564-0800 |
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Product ID | 73564-800_ea39c771-5a73-30d7-e053-2995a90a5118 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Lidonex |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Lidocaine Hcl |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | TOPICAL |
Active Ingredient Strength | 4 |
Active Ingredient Units | g/100mL |
Substance Name | LIDOCAINE HYDROCHLORIDE |
Labeler Name | Newpharma, 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 73564-0800-02 (73564080002)
NDC Package Code | 73564-800-02 |
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Billing NDC | 73564080002 |
Package | 60 mL in 1 BOTTLE (73564-800-02) |
Marketing Start Date | 2022-10-04 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ea39cd13-cacf-3d69-e053-2995a90a7906 Details
SPL UNCLASSIFIED SECTION
Warnings
For external use only
Flammable: Keep away from fire or flame
Do not use
- on wounds or damaged skin
- in large quantaties
- with a heating pad
- if you are allergic to any ingredients of this product
When using this product
- use only as directed.
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
Stop use and ask doctor if
- skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- condition worsens
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
LIDONEX
lidocaine hcl liquid |
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Labeler - Newpharma, Inc. (019170437) |
Revised: 10/2022
Document Id: ea39c771-5a73-30d7-e053-2995a90a5118
Set id: ea39cd13-cacf-3d69-e053-2995a90a7906
Version: 1
Effective Time: 20221004