NDC 0280-0039 Aleve Arthritis Pain Gel

Diclofenac Sodium

NDC Product Code 0280-0039

NDC CODE: 0280-0039

Proprietary Name: Aleve Arthritis Pain Gel 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 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

NDC 0280-0039-01

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

NDC 0280-0039-02

Package Description: 1 TUBE in 1 CARTON > 50 g in 1 TUBE

NDC Product Information

Aleve Arthritis Pain Gel with NDC 0280-0039 is a a human over the counter drug product labeled by Bayer Healthcare Llc. The generic name of Aleve Arthritis Pain Gel is diclofenac sodium. The product's dosage form is gel and is administered via topical form.

Labeler Name: Bayer Healthcare Llc

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.

Aleve Arthritis Pain Gel 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 1 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 (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • WATER (UNII: 059QF0KO0R)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
  • AMMONIA (UNII: 5138Q19F1X)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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.

Product Labeler Information

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

Labeler Name: Bayer Healthcare Llc
Labeler Code: 0280
FDA Application Number: ANDA211253 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: 06-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Aleve Arthritis Pain Gel 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

Other

Drug Facts

  • Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin.
  • Symptoms may include:hivesasthma (wheezing)skin reddeningblistersfacial swellingshockrashIf 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 directedwhen using other drugs containing diclofenac

  • Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
  • Are age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this productapply 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.

Otc - Active Ingredient

Active Ingredient Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug

Otc - Purpose

Arthritis pain reliever

Uses

  • For 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 only

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 surgeryon 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 youyou 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 18 years.

Ask A Doctor Or Pharmacist Before Use

  • Under a doctor's care for any serious conditiontaking any other drug

When Using This Product

  • Avoid contact with eyes, nose, or mouthif eye contact occurs, rinse thoroughly with water

Stop Use And Ask A Doctor If

  • Pain gets worse or lasts more than 21 daysredness or swelling is present in the painful areafever occursskin irritation occursany new symptoms appear. These could be signs of a serious condition.you experience any of the following signs of stomach bleeding:
  • Feel fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get betteryou have symptoms of heart problems or stroke:
  • Chest paintrouble breathingleg swellingweakness in one part or side of bodyslurred speech

Otc - Pregnancy Or Breast Feeding

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 (1-800-222-1222).

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.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 (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 for longer than directedapply to only clean, dry skin that does not have cuts, open wounds, infections or rashesdo not apply in the same area as any other productdo not apply with external heat such as heating paddo not apply to bandage over the treated areastore ENCLOSED DOSING CARD with your ALEVE Arthritis Pain. The dosing cards is re-usable.

Other Information

  • Store at 20-25°C (68-77°F). Keep from freezing.read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.

Inactive Ingredients

CARBOMER HOMOPOLYER TYPE C, COCOYL CAPRYLOCAPRATE, FRAGRANCE, ISOPROPYL ALCOHOL; MINERAL OIL; POLYOXYL 20 CETOSTEARYL ETHER; PROPYLENE GLYCOL, PURIFIED WATER, STRONG AMONIA SOLUTION

Otc - Questions

Questions or Comments 1-800-395-0689

* Please review the disclaimer below.