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DICLOFENAC 1% GEL 100GM - 10 mg/g GEL
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DICLOFENAC 1% GEL 100GM

Generic: diclofenac sodium topical gel, 1%

DICLOFENAC 1% GEL 100GM

NDC:43598-0977-10
Manufacturer:Dr. Reddy's Laboratories Inc.
Strength:10 mg/g
Dosage Form:GEL
Route:TOPICAL

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Drug Information

Identification

Generic Name

diclofenac sodium topical gel, 1%

Brand Name

DICLOFENAC SODIUM

Labeler / Distributor

Dr. Reddy's Laboratories Inc.

Product Type

HUMAN OTC DRUG

Administration

Dosage Form

GEL

Route of Administration

TOPICAL

FDA Application Number

ANDA210986

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM10 mg/g

Pharmacological Class

Anti-Inflammatory AgentsNon-Steroidal [CS]Cyclooxygenase Inhibitors [MoA]Decreased Prostaglandin Production [PE]Nonsteroidal Anti-inflammatory Drug

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Clinical Drug 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

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.

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.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.