FDA label ada43056-a3cf-e7de-e053-2a95a90aa046

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
a264f546-4222-59b0-e053-2995a90a58e5
SPL ID
ada43056-a3cf-e7de-e053-2a95a90aa046
Version
2
Effective date
2020-08-24
Source export date
2026-08-01
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:09:11

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 Stomach bleeding warning This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others) • take a blood thinning (anticoagulant) or steroid drug • have three or more alcoholic drinks every day while using this product • take more or for a longer time than directed Do not use • on the face or rashes; on wounds or damaged skin • in the eyes, mouth, or other mucous membranes • on genitals • with a heating pad • if allergic to any NSAIDS • right before or after heart surgery • any patch from a pouch that has been opened for 7 or more days Ask a doctor before use if • you are allergic to topical products • the stomach bleeding warning applies to you • you are taking a diuretic • you have high blood pressure, heart disease, or kidney disease • you are pregnant When using this product • wash hands after applying or removing patch • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed. Stop use and consult your physician if • stomach pain or upset gets worse or lasts • rash, irritation, or itching develops • you feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding) • condition worsens If pregnant or breast feeding, ask a doctor before use while breast feeding and during the first 6 months of pregnancy. Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.

warnings

Stomach bleeding warning This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others) • take a blood thinning (anticoagulant) or steroid drug • have three or more alcoholic drinks every day while using this product • take more or for a longer time than directed