FDA label b60e5b37-e699-d454-e053-2995a90aee59

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: 324146a5-e473-4a54-8543-38ee567e815e
SPL ID: b60e5b37-e699-d454-e053-2995a90aee59
Version: 4
Effective date: 2020-12-09
Source export date: 2026-08-01
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run: 20260801T225920Z
Imported at: 2026-08-01 23:20:47

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		b60e5b37-e699-d454-e053-2995a90aee59	id
spl set id		324146a5-e473-4a54-8543-38ee567e815e	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