FDA Label for Voltaren Arthritis Pain
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN.
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- DIRECTIONS
- READ THE ENCLOSED CONSUMER USER GUIDE FOR COMPLETE INSTRUCTIONS:
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- USE ENCLOSED DOSING CARD TO MEASURE A DOSE
- PRINCIPAL DISPLAY PANEL
Voltaren Arthritis Pain Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Diclofenac sodium 1% (NSAID*)
*nonsteroidal anti-inflammatory drug
Purpose
Arthritis pain reliever
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
If swallowed, get medical help or contact a Poison Control Center right away.
Uses
• for the treatment of arthritis pain ONLY in the following areas:o hand, wrist, elbow (upper body areas)o 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
Warnings
For external use only
Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
• more or for a longer time than directed• when using other drugs containing diclofenac• 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
• 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
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach
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/fever reducer• for strains, sprains, bruises or sports 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 Use 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
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. 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• you experience any of the following signs of stomach bleeding:o feel fainto have bloody or black stoolso vomit bloodo have stomach pain that does not get better
• you have symptoms of heart problems or stroke:• slurred speech
If Pregnant Or Breast-Feeding,
ask a health professional before use. It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Directions
Use up to 21 days unless directed by your doctor
Daily | Per Dose |
For your arthritis pain: | Use ENCLOSED DOSING CARD to measure a dose |
Read The Enclosed Consumer 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
Other Information
• store at 20-25°C (68-77°F). Keep from freezing.• read all product information before using. Keep the dosing card, this box and accompanying leaflet for important information.
Inactive Ingredients
carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution
Questions Or Comments?
1-855-297-3031
Use Enclosed Dosing Card To Measure A Dose
How to Use
◻ For arthritis pain only◻ Use 4 times a day◻ May take up to 7 days to work for your arthritis pain◻ For use on no more than 2 body areas◻ Use up to 21 days unless directed by your doctor
Principal Display Panel
NDC 0067-8152-02
Voltaren
ARTHRITIS PAIN
NEW
Diclofenac sodium 1% (NSAID) • Arthritis Pain Relieving Gel
For Daily Treatment of Arthritis Pain
Anti-Inflammatory
FULL PRESCRIPTION STRENGTH
TREATMENT AREAS
Powerful Medicated Gel
Clinically Proven to Treat Arthritis Pain
Voltaren Emulgel TM
• For Daily Treatment of Arthritis Pain• Anti-Inflammatory• Non Greasy Gel• Clean Scent
Not for use on any other body area (such as back, hip, or shoulder)
Non Greasy Gel
Clean Scent
NET WT 1.76 oz (50 g)
Made in Canada
Distributed by: GSK Consumer Healthcare, Warren NJ 07059
Trademarks are owned by or licensed to the GSK group of companies.
NDC 0067-8153-01
Voltaren
ARTHRITIS PAIN
Diclofenac sodium 1% (NSAID) • Arthritis Pain Relieving Gel
FULL PRESCRIPTION STRENGTH
NEW
Powerful Medicated Gel
Clinically Proven to Treat Arthritis Pain
Voltaren Emulgel TM
TREATMENT AREAS
EASY TWIST CAP*
Not for use on any other body area (such as back, hip, or shoulder)
NET WT 2 x 150 g + 50 g (350 g)
Made in Canada
Distributed by: GSK Consumer Healthcare, Warren NJ 07059
Trademarks are owned by or licensed to the GSK group of companies.
* Please review the disclaimer below.