FDA label b83153a0-419e-4362-a876-ddf71cf0df96

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
c0fb262e-6ab8-4ee8-a762-10cdcd92eb23
SPL ID
b83153a0-419e-4362-a876-ddf71cf0df96
Version
2
Effective date
2020-10-22
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:27

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 When using this product • read inside of carton before using • use only as directed. Read and follow all directions and warnings on this pouch. • avoid contact with the eyes and mucous membranes • rare cases of serious burns have been reported with products of this type • do not bandage tightly or apply local heat (such as heating pads) • do not apply to wounds or damaged, broken or irritated skin • do not use at the same time as other topical analgesics • discontinue use at least 1 hour before a bath or shower • a transient burning sensation may occur upon application but generally disappears in several days • if severe burning occurs, discontinue use immediately and read inside carton for important information • 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 • condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur again within a few days • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast feeding, ask a health professional before use. If pregnancy 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.

Reported adverse events (FAERS/openFDA)#

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