Diclofenac Sodium 1% Ophthalmic Gel

NDC: 43598-977-10

Diclofenac Sodium Topical Gel 1%, 100 g — Dr. Reddy's Laboratories

Active ingredient	Diclofenac sodium (NSAID) 10 mg/g (1%)
Dosage form	Topical gel, multi-use tube
Route	Topical (external use only)
Size	100 g tube
Manufacturer	Dr. Reddy's Laboratories Inc.
NDC	43598-977-10

Indications and Usage

An NSAID (nonsteroidal anti-inflammatory drug) indicated for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle, or knee. May take up to 7 days to produce pain relief; not intended for immediate relief. Not indicated for strains, sprains, bruises, or sports injuries.

Dosage and Administration

Apply 4 times daily using the enclosed dosing card. For each upper body area (hand, wrist, or elbow), apply 2.25 inches (2 grams). For each lower body area (foot, ankle, or knee), apply 4.5 inches (4 grams). Do not apply to more than 2 body areas at the same time. Apply only to clean, dry, intact skin. Use for up to 21 days unless otherwise directed by a doctor.

Warnings and Precautions

• For external use only; avoid contact with eyes, nose, or mouth — do not use in the eyes, nose, or mouth
• Allergy alert: may cause a severe allergic reaction, especially in patients allergic to aspirin (symptoms may include hives, wheezing, skin reddening, blisters, facial swelling, shock, or rash); discontinue and seek medical help immediately if this occurs
• Liver warning: liver damage may occur if applied more often or longer than directed, or when used with other diclofenac-containing products
• Stomach bleeding warning: contains an NSAID; risk of severe stomach bleeding is small but increased in patients age 60+, with prior stomach ulcers/bleeding, taking anticoagulants or steroids, taking other NSAIDs, consuming 3+ alcoholic drinks daily, or applying more/longer than directed
• Heart attack and stroke warning: NSAIDs (except aspirin) increase risk of heart attack, heart failure, and stroke, which can be fatal; risk increases with use beyond directed amount or duration
• Do not apply with external heat (e.g., heating pad) or cover the treated area with a bandage
• Not for use immediately before or after heart surgery

Contraindications

Do not use in patients with a history of allergic reaction to aspirin or other pain relievers/fever reducers. Not for use on strains, sprains, bruises, or sports injuries.

Adverse Reactions

Discontinue use and consult a doctor if pain worsens or persists beyond 21 days, if redness, swelling, fever, or skin irritation occurs, or if any new symptoms appear. Seek immediate medical attention for signs of stomach bleeding (fainting, bloody or black stools, vomiting blood, persistent stomach pain) or signs of heart attack/stroke (chest pain, trouble breathing, leg swelling, one-sided weakness, slurred speech).

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F). Keep from freezing.

How Supplied

Supplied as a 100 g tube in a carton with enclosed dosing card and User Guide. Also available in 20 g, 50 g, 100 g (2-pack), and 150 g tube sizes.

Consumer/professional reference only. Clinical information summarized from FDA-required Drug Facts labeling; refer to the full product labeling via DailyMed for complete details.