Arthritis Pain 10 mg/g
diclofenac sodium topical gel, 1% · GEL · Discount Drug Mart, Inc.
Diclofenac sodium topical gel is a nonsteroidal anti-inflammatory medication applied directly to the skin to relieve arthritis pain and inflammation in affected joints. This over-the-counter product works locally at the site of application to help reduce pain and improve mobility.
Key Facts
- Brand Name
- Arthritis Pain
- Generic Name
- diclofenac sodium topical gel, 1%
- NDC Code (Product)
53943-523- Manufacturer
- Discount Drug Mart, Inc.
- Strength
- 10 mg/g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA210986
- Marketing Start
- 07/06/2022
Recall History
Beaumont Bio-med, Inc.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
King Bio Inc.
Microbial contamination
King Bio Inc.
Microbial contamination
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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.
Dosage & Administration
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 • For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams) • For each lower body area (foot, ankle or knee) – Squeeze out 4.5 inches (4 grams) 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 the 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% product. The dosing card is re-usable.
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 is you use more than directed or for longer than directed. Do …
Frequently Asked Questions
What is Arthritis Pain used for?
Diclofenac sodium topical gel is a nonsteroidal anti-inflammatory medication applied directly to the skin to relieve arthritis pain and inflammation in affected joints. This over-the-counter product works locally at the site of application to help reduce pain and improve mobility.
Is Arthritis Pain a controlled substance?
Arthritis Pain is not classified as a controlled substance by the DEA.
What is the generic name for Arthritis Pain?
The generic name for Arthritis Pain is diclofenac sodium topical gel, 1%. There are 11 other brand versions of diclofenac sodium topical gel, 1%.
What is the NDC code for Arthritis Pain 10 mg/g?
The NDC (National Drug Code) for Arthritis Pain 10 mg/g is 53943-523, listed by Discount Drug Mart, Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)