Crcle Diclofenac Sodium Topical Gel 1% DICLOFENAC SODIUM TOPICAL 1% INNOVUS PHARMACEUTICALS 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.
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Substance Diclofenac Sodium
Route
TOPICAL
Applications
ANDA210986
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 ispropyl 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

Carton NDC 57483-596-01 ORIGINAL PRESCRIPTION STRENGTH Crcle Diclofenac Sodium Topical Gel, 1% (NSAID)- Arthritis pain reliever Anti-inflammatory For daily treatment of arthritis pain FOR EXTERNAL USE ONLY Compare to the active ingredient in Voltaren Arthritis Pain Gel** NET WT 5.29 oz (150 g) image description

Package Descriptions
  • Carton NDC 57483-596-01 ORIGINAL PRESCRIPTION STRENGTH Crcle Diclofenac Sodium Topical Gel, 1% (NSAID)- Arthritis pain reliever Anti-inflammatory For daily treatment of arthritis pain FOR EXTERNAL USE ONLY Compare to the active ingredient in Voltaren Arthritis Pain Gel** NET WT 5.29 oz (150 g) image description

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 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.
Purpose

Purpose Arthritis pain reliever

Do Not Use

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

When Using

When using this product avoid contact with eyes, nose, or mouth if eye contact occurs, rinse thoroughly with water

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

Question and comments? 1-833-285-4151


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