FDA label b60e7299-46f9-6c6e-e053-2a95a90ae096

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: 81551489-c68a-4d2d-b07b-333ead22e8f1
SPL ID: b60e7299-46f9-6c6e-e053-2a95a90ae096
Version: 4
Effective date: 2020-12-09
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 05:50:04

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		b60e7299-46f9-6c6e-e053-2a95a90ae096	id
spl set id		81551489-c68a-4d2d-b07b-333ead22e8f1	set_id

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 Warning: KEEP OUT OF REACH OF CHILDREN Do not use if allergic to benzocaine or any other ingredient in the product. Use with caution in children. Do not use in large quantities or over large areas of the body. Methemoglobinemia Warning: Products containing Benzocaine may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if this product was used before. Stop use and seek immediate attention if you or your child develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or light-headedness and fatigue or lack of energy. Drug Facts Table: https://www.medicom.com/en/products/61/pro-freeze-topical-anesthetic-gel/50/pro-freeze-topical-anesthetic-gel-18-benzocaine-2-tetracaine

warnings and cautions

Warnings and Precautions/ Drug Interactions/ Patient Counceling Information Warning 1

Reported adverse events (FAERS/openFDA)#

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