UltraCare Anesthetic Gel

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
UltraCare Anesthetic Gel
Generic name
BENZOCAINE
Manufacturer
The Bellport Company, Inc. dba Gingi-Pak
Product type
HUMAN OTC DRUG
SPL set ID
f5dd8fa8-0b6a-5a30-e053-2995a90ad194
SPL ID
552ed026-466f-4311-e063-6394a90ad1b6
Version
3
Effective date
2026-06-26
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:27:49
Harmonized routes table
Harmonized routes
DENTAL, PERIODONTAL, TOPICAL

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

Warnings For external use only. Stop use and ask a doctor if - Sore throat is severe and more than 2 days - Fever, headache, rash, nausea, or vomiting develops - Mouth sore does not go away within 10 days - Irritation, pain or redness worsens Ask a doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes. Methemoglobinemia warning Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated prompltly because it reduces the amount of oxygen carried in blood. Cease use and seek immediate medical attention if one of the following symptoms develops: -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 patients with history of hypersensitivity to any ester-type local anesthetics. Do not use the product for teething or in infants and children younger than 2 years. Do not use if you have history of allergy to any "caine" local anesthetics. Avoid contact with eyes. Keep out of reach of children. If more than normal usage amount if accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not exceed recommended dosage.

warnings

Methemoglobinemia warning Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated prompltly because it reduces the amount of oxygen carried in blood. Cease use and seek immediate medical attention if one of the following symptoms develops: -Pale, gray, or blue colored skin (cyanosis) - Headache - Rapid heart rate - Shortness of breath _ Dizziness or lightheadedness - Fatigue or lack of energy

Reported adverse events (FAERS/openFDA)#

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