CareOne arthritis pain relief

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
CareOne arthritis pain relief
Generic name
DICLOFENAC SODIUM
Manufacturer
American Sales Company
Product type
HUMAN OTC DRUG
SPL set ID
69615972-b593-44fb-ae49-9441d872d84a
SPL ID
35cb0cc5-004a-434a-91a4-e8cfc051cae2
Version
4
Effective date
2023-06-08
Source export date
2026-08-08
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/2ef638b6b5a68e854d11a3945e1b1aa8d0e7f812a9d69af10df01eecf2e189d0/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 18:07:26
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 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 help right away. Liver warning: This product contains diclofenac. Liver damage may occur if you apply • more or for a longer time than directed • 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 nonprescription 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. Do not use • if you have ever had an allergic reaction to any other pain reliever or to a fever reducer • for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. • right before or after heart surgery • on more than 2 body areas at the same time • in the eyes, nose or mouth Ask a doctor before us if • you have problems or serious side effects from taking pain relievers or fever reducers • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic • you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years. Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking any other drug When using this product • avoid contact with eyes, nose, or mouth • if eye contact occurs, rinse thoroughly with water Stop use and ask a doctor if • pain gets worse or lasts more than 21 days • redness or swelling is present in the painful area • fever occurs • skin irritation occurs • any new symptoms appear. These could be signs of a serious condition. • you experience any of the following signs of stomach bleeding: • feel faint • have bloody or black stools • vomit blood • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • leg swelling • weakness in one part or side of body • slurred speech If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).