FDA label ff5c8c63-4938-a17d-e053-6294a90ae14d

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
f8221362-108f-4ee9-e053-6394a90a5064
SPL ID
ff5c8c63-4938-a17d-e053-6294a90ae14d
Version
3
Effective date
2023-06-30
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:29:59

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 Topical use only Allergy Alert : Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: Hives Asthma (wheezing) Skin Reddening Blisters Facial Swelling Shock Rash If an allergic reaction occurs, stop use and seek medical attention immediately. Liver Warning : This product contains Diclofenac. Liver damage may occur if you apply (1) more or for a longer time than directed or (2) when using other drugs containing Diclofenac. Stomach Bleeding Warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is small, but higher if you: Are age 60 or older Have had stomach ulcers or bleeding problems Take a blood thinning (anticoagulant) or steroid drug Take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others) Have 3 or more alcoholic drinks every day while using this product Apply more or for longer than directed Heart Attack and Stroke Warning : NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Reported adverse events (FAERS/openFDA)#

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