NDC 43598-885 Diclofenac Sodium

Diclofenac Sodium Topical Gel, 1%

NDC Product Code 43598-885

NDC CODE: 43598-885

Proprietary Name: Diclofenac Sodium What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Diclofenac Sodium Topical Gel, 1% What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

NDC Code Structure

  • 43598 - Dr. Reddy's Laboratories Inc.

NDC 43598-885-10

Package Description: 1 TUBE in 1 CARTON > 100 g in 1 TUBE

NDC Product Information

Diclofenac Sodium with NDC 43598-885 is a a human over the counter drug product labeled by Dr. Reddy's Laboratories Inc.. The generic name of Diclofenac Sodium is diclofenac sodium topical gel, 1%. The product's dosage form is gel and is administered via topical form.

Labeler Name: Dr. Reddy's Laboratories Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Diclofenac Sodium Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DICLOFENAC SODIUM 10 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • AMMONIA (UNII: 5138Q19F1X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dr. Reddy's Laboratories Inc.
Labeler Code: 43598
FDA Application Number: ANDA210986 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Diclofenac Sodium Product Label Images

Diclofenac Sodium Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Diclofenac sodium (NSAID*) 1% *nonsteroidal anti‑inflammatory drug

Inactive Ingredients

Inactive ingredients: Carbomer Homopolymer Type C, Coco-Caprylate/caprate, Isopropyl Alcohol, Mineral Oil, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Purified Water, Strong Ammonia Solution

Purpose

Arthritis pain reliever

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

  • For external use onlyAllergy 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   • rashIf an allergic reaction occurs, stop use and seek medical help right away.Liver warning: This product contains diclofenac. Liver damage may occur if you applymore or for a longer time than directedwhen using other drugs containing diclofenacStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if youare age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this productapply more or for longer than directedHeart 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 reducerfor 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 timein the eyes, nose or mouth

Ask A Doctor Before Use If

  • You have problems or serious side effects from taking pain relievers or fever reducersstomach bleeding warning applies to you you have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a strokeyou are taking a diureticyou 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 conditiontaking 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 areafever occurs                                                     skin irritation occursany new symptoms appear. These could be signs of a serious condition.you experience any of the following signs of stomach bleedingfeel faint have bloody or black stools vomit blood have stomach pain that does not get betteryou have symptoms of heart problems or strokechest pain trouble breathingleg swellingweakness 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 this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Use up to 21 days unless directed by your doctorNot for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.DailyPer DoseFor your arthritis pain:Use 4 times per day every dayDo not use on more than 2 body areas at the same timeUse ENCLOSED DOSING CARD to measure a doseFor 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 directeddo not use more than directed or for longer than directedapply only to clean, dry skin that does not have any cuts, open wounds, infections or rashesdo not apply in same area as any other productdo not apply with external heat such as heating pad do not apply a bandage over the treated areastore ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% Arthritis Pain. The dosing card is re-usable.

Other Information

  • Store at 20-25oC (68°F - 77°F). Keep from freezing. read all product information before using. Keep the dossing card, the carton and accompanying User guide for important information.Inactive ingredientsCarbomer homopolymer Type C, cocoyl caprylocaprate, ispropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution.Question and comments 1-833-285-4151

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