FDA.reportPublic FDA data

Gingicaine Gel Strawberry

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 Strawberry
Generic name
GINGICAINE GEL STRAWBERRY FLAVOR
Manufacturer
Gingi-Pak a Division of the Belport
Product type
HUMAN OTC DRUG
SPL set ID
2fd37612-a28b-3aa1-e054-00144ff8d46c
SPL ID
50cb6dbf-74de-4f3a-e063-6394a90a21bb
Version
13
Effective date
2026-05-01
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:47:45
Harmonized routes table
Harmonized routes
DENTAL, ORAL, PERIODONTAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Precaution Section Dentists should avoid application to severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes. Local anesthetics should be used with caution in patients with known drug sensitivities, particularly those known to be allergic to ester-type anesthetics (procaine, benzocaine, tetracaine). Dentists should avoid contact with all local anesthetics to avoid possible sensitization.

warnings

Warnings For topical use only. 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 Do not use in children under 2 years of age.

Reported adverse events (FAERS/openFDA)#

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