Drugplain

Arthritis Pain Reliever 10 mg/g

Diclofenac sodium · GEL · P & L Development, LLC

No Recall History
Plain English

Diclofenac sodium gel is a nonsteroidal anti-inflammatory medication (NSAID) that you apply directly to your skin to relieve arthritis pain and inflammation in affected joints. This over-the-counter topical gel allows the medication to work at the site of pain without being absorbed into your bloodstream like oral pain relievers.

Key Facts

Brand Name
Arthritis Pain Reliever
Generic Name
Diclofenac sodium
NDC Code (Product)
59726-012
Manufacturer
P & L Development, LLC
Strength
10 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
ANDA208077
Marketing Start
06/25/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use24,836 reports
fatigue23,734 reports
drug ineffective22,519 reports
pain21,888 reports
nausea19,329 reports
headache18,366 reports
arthralgia16,218 reports
dyspnoea15,753 reports
toxicity to various agents15,650 reports
vomiting15,506 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 Reliever used for?

Diclofenac sodium gel is a nonsteroidal anti-inflammatory medication (NSAID) that you apply directly to your skin to relieve arthritis pain and inflammation in affected joints. This over-the-counter topical gel allows the medication to work at the site of pain without being absorbed into your bloodstream like oral pain relievers.

Is Arthritis Pain Reliever a controlled substance?

Arthritis Pain Reliever is not classified as a controlled substance by the DEA.

What is the generic name for Arthritis Pain Reliever?

The generic name for Arthritis Pain Reliever is Diclofenac sodium. There are 11 other brand versions of Diclofenac sodium.

What is the NDC code for Arthritis Pain Reliever 10 mg/g?

The NDC (National Drug Code) for Arthritis Pain Reliever 10 mg/g is 59726-012, listed by P & L Development, LLC.

Product NDC

59726-012

Package NDC

59726-012-50

Other Arthritis Pain Reliever Dosages

Other Diclofenac Brands

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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)