FDA label 512e31c8-e664-45c4-a167-218480cf2101

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
3ca83527-f3de-49df-b6b2-a16be8aed059
SPL ID
512e31c8-e664-45c4-a167-218480cf2101
Version
2
Effective date
2024-03-11
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:31:51

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS 1. Do not use : On the face or rashes On wounds, damaged or infected skin On eyes, mouth, genitals, or other mucous membranes With a bandage or heating pad 2. Consult physician for children under 12 years of age 3. Stop and consult your prescriber If pain worsens If you are allergic to any of the ingredients in this product If excessive skin irritation develops If using concurrently with any other external pain-relieving products If you are pregnant, planning to become pregnant, or breastfeeding If symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: Shortness of breath Swelling or numbness of the tongue or throat Severe headache or vomiting Dizziness or faintness Changes in vision or speech Excessive dosage, or short interval between doses, can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs. General information about the safe and effective use Gen7T Lotion ® Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use this product for another indication unless instructed and prescribed by a physician. Do not give this drug to anyone else, even if they have the same condition. This product is intended for use as prescribed by a physician. How should I store Gen7T Lotion ® Store product at room temperature at 68°F to 77°F (20°C to 25°C). Keep away from heat or sunlight. Protect from excessive moisture. Safely discard product after expiration date posted on the product label. Discard this product away from small children or animals. DO NOT use the product after the expiration date printed on the bottle. What are the active ingredients in Gen7T Lotion ® ? The lotion consists of 3.5% lidocaine.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS: The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time. Serious adverse experiences following the administration of Gen7T Lotion ® are similar in nature to those observed in other amide anesthetic-containing agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.