DICLOFENAC SODIUM
Generic: DICLOFENAC SODIUM TOPICAL GEL, 1%
Basic Information
Manufacturer
BluePoint Laboratories
Product Type
HUMAN OTC DRUG
Route of Administration
TOPICAL
FDA Set ID
274543d2-a9a6-1e37-e063-6394a90ae3f1
Purpose
Purpose Arthritis Pain Reliever
Indications & Usage
Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief.
If no pain relief in 7 days, stop use
If no pain relief in 7 days, stop use
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 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.
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 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.