Drugplain

Voltaren Arthritis Pain 10 mg/g

diclofenac sodium · GEL · Haleon US Holdings LLC

1 Recall on Record
Plain English

Voltaren Arthritis Pain is a gel containing diclofenac sodium at 10 mg/g, taken topical. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
Voltaren Arthritis Pain
Generic Name
diclofenac sodium
NDC Code (Product)
0067-8152
Manufacturer
Haleon US Holdings LLC
Strength
10 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
NDA022122
Marketing Start
05/13/2020

Recall History

1 Recall on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective23,370 reports
product use in unapproved indication11,698 reports
off label use9,816 reports
pain9,610 reports
fatigue8,626 reports
product use issue7,780 reports
rash7,449 reports
product administered at inappropriate site6,949 reports
rheumatoid arthritis6,937 reports
drug effective for unapproved indication6,759 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: 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. 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)

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 if you use more than directed or for longer than directed. Do …

Frequently Asked Questions

What is Voltaren Arthritis Pain used for?

Voltaren Arthritis Pain contains diclofenac sodium. It is a gel taken topical. Consult your doctor for specific uses.

Is Voltaren Arthritis Pain a controlled substance?

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

What is the generic name for Voltaren Arthritis Pain?

The generic name for Voltaren Arthritis Pain is diclofenac sodium. There are 10 other brand versions of diclofenac sodium.

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

The NDC (National Drug Code) for Voltaren Arthritis Pain 10 mg/g is 0067-8152, listed by Haleon US Holdings LLC.

Product NDC

0067-8152

Package NDC

0067-8152-01

Other Voltaren Arthritis Pain 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)