GingiCaine Gel, Mint Julep

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)

Brand name
GingiCaine Gel, Mint Julep
Generic name
GINGICAINE GEL, MINT JULEP FLABVOR
Manufacturer
Gingi-Pak a Division of the Belport
Product type
HUMAN OTC DRUG
SPL set ID
6285fe10-08ba-8044-e053-2991aa0a8e8b
SPL ID
556bc050-ae23-db1d-e063-6294a90a988f
Version
3
Effective date
2026-06-29
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:36:50
Harmonized routes table
Harmonized routes
DENTAL, ORAL, PERIODONTAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use if you have a history of hypersensitivity to ester–type local anesthetics, not for use with teething or children under 2 years of age. For topical use only Methemoglobinemia warning Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Consumers are advised to cease use and seek immediate medical attention if they or a child in their care develop: • Pale, gray, or blue colored skin (cyanosis) • Headache • Rapid heart rate • Shortness of breath • Dizziness or lightheadedness • Fatigue or lack of energy Stop use and ask a doctor if (signs of toxicity) • Sore throat is severe and more than 2 days • Fever, headache, rash, nausea, or vomiting develops • Mouth sores do not go away in 7 days • Irritation, pain, or redness worsens

Reported adverse events (FAERS/openFDA)#

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