Biofreeze Ultraflex

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
Biofreeze Ultraflex
Generic name
LIDOCAINE
Manufacturer
Reckitt Benckiser LLC
Product type
HUMAN OTC DRUG
SPL set ID
2655974b-a67d-9f07-e063-6294a90a54e8
SPL ID
5348f92e-a770-de13-e063-6294a90adbcc
Version
5
Effective date
2026-06-02
Source export date
2026-08-01
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/f23e8214fa581dc87bce024b3f15739356a8bb6f9298e3d6be38c21c662a4211/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:07:50
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Do not use 􀂄 more than 1 patch on your body at a time or with other topical anesthetics at the same time 􀂄 on wounds, damaged skin, rashes, or swollen skin 􀂄 with a heating pad or apply local heat to the area of use 􀂄 in large quantities, particularly over raw surfaces or blistered areas When using this product 􀂄 use only as directed 􀂄 do not bandage tightly 􀂄 avoid contact with the eyes or on mucous membranes 􀂄 dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. Stop use and ask a doctor if 􀂄 the condition for which this preparation is used persists or if a rash, redness or irritation develops 􀂄 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within few days 􀂄 you experience pain, swelling or blistering of the skin If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children and pets . If swallowed, get medical help or contact a Poison Control Center right away.