Dolo-neurobion Arthritis Pain Gel
FDA Label NDC 55959-123
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Benard Industries Inc for the product Dolo-neurobion Arthritis Pain (NDC 55959-123). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)
*nonsteroidal anti-inflammatory drug
Purpose
Arthritis pain reliever
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.
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.
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Use up to 21 days unless directed by your doctor.
Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.
| Daily | Per Dose |
| For your arthritis pain: • Use 4 times per day every day • Do not use on more than 2 body areas at the same time | Use ENCLOSED DOSING CARD to measure a dose |
Read the enclosed User Guide for complete instructions:
• use only as directed
• do not use more than directed or for longer than directed
• apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes
• do not apply in same area as any other product
• do not apply with external heat such as heating pad
• do not apply a bandage over the treated area
• store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. The dosing card is re-usable.
Other Information
• store at 20-25°C (68-77°F). Keep from freezing.
• read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.
Inactive Ingredients
carbomer homopolymer Type C, cocoyl caprylocaprate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution.
Questions Or Comments?
Call (305) 594-0480
Packaging
* Please review the disclaimer below.