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FDA Approval

Lidothol

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
January 10, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Lidocaine(4.5 g in 1 1)
Menthol(5 g in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Advanced Rx Pharmacy of Tennessee, LLC

Advanced Rx Pharmacy of Tennessee, LLC

117023142

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidothol

Product Details

NDC Product Code
80425-0252
Route of Administration
TOPICAL
Effective Date
January 10, 2023
LidocaineActive
Code: 98PI200987Class: ACTIBQuantity: 4.5 g in 1 1
MentholActive
Code: L7T10EIP3AClass: ACTIBQuantity: 5 g in 1 1

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

label 1


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