Diclofenac sodium DICLOFENAC SODIUM CIPLA USA INC. FDA Approved 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.
FunFoxMeds box
Substance Diclofenac Sodium
Route
TOPICAL
Applications
ANDA209903
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug
Inactive Ingredients
INACTIVE INGREDIENTS carbomer homopolymer Type C cocoyl caprylocaprate fragrance isopropyl alcohol mineral oil polyoxyl 20 cetostearyl ether propylene glycol purified water strong ammonia solution
Strengths
1 % 0.93 %
Treats Conditions
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

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
QTG126297Q
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Cipla NDC 69097-720-44 Diclofenac Sodium Topical Gel, 1% (NSAID) - Arthritis Pain Reliever NET WT 100 g (3.53 oz) Cipla NDC 69097-720-44 Diclofenac Sodium Topical Gel, 1% (NSAID) - Arthritis Pain Reliever For Daily Treatment of Arthritis Pain For external use only Anti-inflammatory NET WT 100 g (3.53 oz) tube-label-dpt carton-label-bora

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Cipla NDC 69097-720-44 Diclofenac Sodium Topical Gel, 1% (NSAID) - Arthritis Pain Reliever NET WT 100 g (3.53 oz) Cipla NDC 69097-720-44 Diclofenac Sodium Topical Gel, 1% (NSAID) - Arthritis Pain Reliever For Daily Treatment of Arthritis Pain For external use only Anti-inflammatory NET WT 100 g (3.53 oz) tube-label-dpt carton-label-bora

Overview

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.

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)

Warnings & Precautions
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 not use if you have ever had an allergic reaction to any other pain reliever or to a fever reducer for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. right before or after heart surgery on more than 2 body areas at the same time in the eyes, nose or mouth Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years. Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug When using this product avoid contact with eyes, nose, or mouth if eye contact occurs, rinse thoroughly with water Stop use and ask a doctor if pain gets worse or lasts more than 21 days redness or swelling is present in the painful area fever occurs skin irritation occurs any new symptoms appear. These could be signs of a serious condition. you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing leg swelling weakness in one part or side of body slurred speech If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Purpose

PURPOSE Arthritis pain reliever

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →