Drugplain

Diclofenac Sodium Topical Gel, 1% 1 g/100g

Diclofenac Sodium Topical Gel, 1% (NSAID) · GEL · Mohnark Pharmaceuticals Inc.

2 Recalls on Record
Plain English

Diclofenac Sodium Topical Gel, 1% is a gel containing diclofenac sodium topical gel, 1% (nsaid) at 1 g/100g, taken topical. Manufactured by Mohnark Pharmaceuticals Inc..

Key Facts

Brand Name
Diclofenac Sodium Topical Gel, 1%
Generic Name
Diclofenac Sodium Topical Gel, 1% (NSAID)
NDC Code (Product)
73715-005
Manufacturer
Mohnark Pharmaceuticals Inc.
Strength
1 g/100g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Marketing Start
08/31/2021

Recall History

2 Recalls on Record
Class III12/22/2025

Cipla USA, Inc.

Failed PH Specifications

OngoingVoluntary: Firm initiated
Class III02/19/2013

Novartis Consumer Health

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use4 reports
erythema3 reports
skin discolouration3 reports
drug ineffective2 reports
gait disturbance2 reports
accidental exposure to product1 reports
apnoea1 reports
application site rash1 reports
application site swelling1 reports
burning sensation1 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 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% Arthritis Pain. 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 non-prescription 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.

Frequently Asked Questions

What is Diclofenac Sodium Topical Gel, 1% used for?

Diclofenac Sodium Topical Gel, 1% contains Diclofenac Sodium Topical Gel, 1% (NSAID). It is a gel taken topical. Consult your doctor for specific uses.

Is Diclofenac Sodium Topical Gel, 1% a controlled substance?

Diclofenac Sodium Topical Gel, 1% is not classified as a controlled substance by the DEA.

What is the generic name for Diclofenac Sodium Topical Gel, 1%?

The generic name for Diclofenac Sodium Topical Gel, 1% is Diclofenac Sodium Topical Gel, 1% (NSAID). There are no other listed brand versions of Diclofenac Sodium Topical Gel, 1% (NSAID).

What is the NDC code for Diclofenac Sodium Topical Gel, 1% 1 g/100g?

The NDC (National Drug Code) for Diclofenac Sodium Topical Gel, 1% 1 g/100g is 73715-005, listed by Mohnark Pharmaceuticals Inc..

Product NDC

73715-005

Package NDC

73715-005-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)