Active Ingredient
Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Arthritis Pain Reliever (NDC 51316-073). 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 active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)
*nonsteroidal anti-inflammatory drug
Arthritis Pain Reliever
For external use only.
Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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 bleeding. The chance is small but higher if you:
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.
ask a health professional before use. It is especially important to not 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.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
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 ENCLOSED DOSING CARD to measure a dose
|
Read the enclosed User Guide for complete instructions:
carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution
Call 1-877-753-3935 Monday-Friday 9 AM- 5 PM EST
Use enclosed dosing card to measure a dose
Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain reliever [Upper body dose 2.25 inches long (2 grams)] Dosing Card (NOT ACTUAL SIZE) [Lower body dose 4.5 inches long (4 grams) Read product User Guide before use Not for immediate pain relief |
How to use
†Compare to the active ingredient in Voltaren® Arthritis Pain Topical Gel
ORIGINAL PRESCRIPTION STRENGTH
Diclofenac Sodium
Topical Gel, 1% (NSAID)
ARTHRITIS PAIN RELIEVER
For External Use only
Medicated gel clinically proven to relieve arthritis pain
NET WT OZ (g)
†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Voltaren® Arthritis Pain Topical Gel.
TAMPER EVIDENT STATEMENT: DO NOT USE IF FOIL SEAL ON TUBE OPENING IS BROKEN OR MISSING.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
* Please review the disclaimer below.