NDC 41520-788 Careone Arthritis Pain Relief

Diclofenac Sodium

NDC Product Code 41520-788

NDC CODE: 41520-788

Proprietary Name: Careone Arthritis Pain Relief 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

  • 41520 - American Sales Company

NDC 41520-788-01

Package Description: 1 TUBE, WITH APPLICATOR in 1 CARTON > 100 g in 1 TUBE, WITH APPLICATOR

NDC Product Information

Careone Arthritis Pain Relief with NDC 41520-788 is a a human over the counter drug product labeled by American Sales Company. The generic name of Careone Arthritis Pain Relief is diclofenac sodium. The product's dosage form is gel and is administered via topical form.

Labeler Name: American Sales Company

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.

Careone Arthritis Pain Relief 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 (ALLYL PENTAERYTHRITOL CROSSLINKED) (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)

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: American Sales Company
Labeler Code: 41520
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: 10-29-2020 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’.

* Please review the disclaimer below.

Careone Arthritis Pain Relief 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% (equivalent to 0.93% diclofenac)*nonsteroidal anti-inflammatory drug

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 apply •more or for a longer time than directed •when 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 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 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 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 Us 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 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 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 day •Do not use on more than 2 body areas at the same timeUse 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% product. The dosing card 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 homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

Diclofenac Sodium Topical Gel, 1% (Nsaid)

  • Arthritis Pain RelieverUser GuideHow to use Diclofenac Sodium Topical Gel, 1% with answers to frequently asked questionsQuick StartHow to get started right away with Diclofenac SodiumTopical Gel, 1%Understanding Diclofenac Sodium Topical Gel, 1%Diclofenac Sodium Topical Gel, 1% (NSAID) – arthritis pain reliever is an arthritis pain relief medication that you apply to your skin.Before You Use Diclofenac Sodium Topical Gel, 1%Read the Drug Facts Label, which appears on the carton.Remove the dosing card from the inside of the carton. You should always use the dosing card to measure out the correct dose of Diclofenac Sodium Topical Gel, 1%. The first time you use a tube of Diclofenac Sodium Topical Gel, 1%:The first time you use a tube of Diclofenac Sodium Topical Gel, 1%:1. Take the cap off the tube.2. Open the safety seal by firmly pressing the point on the top of the cap onto the seal on the tube. Do not open the safety seal with scissors or other sharp objects.3. After use, put the cap back on the end of the tube.Using Diclofenac Sodium Topical Gel, 1%How often to use Diclofenac Sodium Topical Gel, 1%Use 4 times a day for best results.For example:Where to apply Diclofenac Sodium Topical Gel, 1%Diclofenac Sodium Topical Gel, 1% can be used on up to 2 body areas from the following list: a hand, a wrist, an elbow, a foot, an ankle, a knee. Do not use on more than 2 body areas at once.Some examples include:Measuring the correct amount using the dosing cardFor each upper body area (a hand, a wrist, or an elbow): Squeeze gel from the tube equal to the length shown on the upper body section of the dosing card (2.25 inches).For each lower body area (a foot, an ankle, or a knee): Squeeze gel from the tube equal to the length shown on the lower body section of the dosing card (4.5 inches).Lost Your Dosing Card? Don’t worry!Call 1-800-719-9260 to get a free replacement.Applying Diclofenac Sodium Topical Gel, 1%Gently rub Diclofenac Sodium Topical Gel, 1% into the skin using your hand. Apply 4 times a day for best results. Do not use on more than 2 body areas at once.Apply only to clean, dry skin that doesn’t have any cuts, open wounds, infections or rashes. Do not apply in the same area as any other medicines or products that are applied to the skin.After You Use Diclofenac Sodium Topical Gel, 1%Wash your hands after applying Diclofenac Sodium Topical Gel, 1%. If the treated area is the hands wait up to 1 hour to wash the hands.Wash the dosing card with water. Store dosing card with your Diclofenac Sodium Topical Gel, 1% and keep out of reach of children.Wait ten minutes before covering the treated areas with clothes or gloves.Avoid: •showering or bathing for at least 1 hour after use •exposing the treated area to sunlight or artificial light (such as in tanning booths) •use in same area as other products applied to the skin •applying a bandage over the treated area •eye, nose, or mouth contact •if eye contact occurs, rinse thoroughly with waterFacts you need to knowImportant information about Diclofenac Sodium Topical Gel, 1%Do not use Diclofenac Sodium Topical Gel, 1%... •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 • you are taking any other drug •you are pregnant or breast-feedingIt 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.Warnings to consider before use...Allergy alertDiclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: •hives •blisters •asthma (wheezing) •facial swelling •skin reddening •shock •rashIf an allergic reaction occurs, stop use and seek medical help right away.Liver warningThis product contains diclofenac. Liver damage may occur if you apply •more or for a longer time than directed •when using other drugs containing diclofenacStomach bleeding warningThis product contains an NSAID, which may cause 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 directedHeart attack and stroke warningNSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. This can be fatal. The risk is higher if you use more than directed or for longer than directed.Follow these important guidelines when using Diclofenac Sodium Topical Gel, 1%... •use only as directed •apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes •do not apply in the same area as any other product used on the skin •do not apply with external heat such as heating pad •do not apply a bandage over the treated area •do not get gel in eyes, nose or mouth •store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. The dosing card is re-usable.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).Stop using Diclofenac Sodium Topical Gel, 1% 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 of side of body •slurred speechQuestions and AnswersAnswers to questions you may ask about Diclofenac Sodium Topical Gel, 1%Can I use Diclofenac Sodium Topical Gel, 1% for the immediate relief of pain like that associated with sprains, strains, bruises, or sports injuries?No.Do not use for strains, sprains, bruises, or sports injuries. This product has not been shown to work for these types of injuries. It’s intended only for the temporary relief of arthritis pain.How quickly will Diclofenac Sodium Topical Gel, 1% work for arthritis pain?Diclofenac Sodium Topical Gel, 1% may take up to 7 days to work for your arthritis pain; it is not for immediate relief. With 4 times-a-day use, you may start to feel relief within a few days. You should feel significant pain relief within 7 days of continuous use. If no pain relief in 7 days, stop use.What is Diclofenac Sodium Topical Gel, 1% used for?Diclofenac Sodium Topical Gel, 1% can be used for the temporary relief of arthritis pain in the hands, wrists, elbows, feet, ankles, and knees. Osteoarthritis (OA) is the most common form of arthritis. It mainly affects a type of tissue called cartilage, which cushions the joints and prevents the bones from rubbing against each other.With OA, cartilage begins to break down and wear away, resulting in joint pain and stiffness. OA occurs more frequently as you get older. Pain develops slowly and can gradually worsen over time.How does Diclofenac Sodium Topical Gel, 1% work?Diclofenac sodium, the medicine in Diclofenac Sodium Topical Gel, 1%, is a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs are used to treat pain from medical conditions such as arthritis. Diclofenac Sodium Topical Gel, 1% works similarly to oral NSAIDs like ibuprofen or naproxen by temporarily blocking the production of pain signaling chemicals called prostaglandins. However, when taking a pill, the medication is distributed to the site of pain through the bloodstream. Compared to oral diclofenac, only 6% of the medicine in Diclofenac Sodium Topical Gel, 1% is absorbed in the bloodstream. It works by penetrating through your skin at the application site to deliver arthritis pain relief.How does over-the-counter Diclofenac Sodium Topical Gel, 1% differ from prescription Diclofenac Sodium Topical Gel, 1%?Over-the-counter Diclofenac Sodium Topical Gel, 1% is the same strength and formula as original full prescription strength Diclofenac Sodium Topical Gel, 1% but is available without a prescription.Apply Diclofenac Sodium Topical Gel, 1% 4 times a day to ensure you get the full effect of the medicine.Can I apply Diclofenac Sodium Topical Gel, 1% to upper and lower body areas at the same time?Yes.You can use Diclofenac Sodium Topical Gel, 1% on up to 2 body areas at the same time. The areas can include the foot, ankle, knee, hand, wrist, and elbow.Some correct examples include:Do not use Diclofenac Sodium Topical Gel, 1% on more than 2 body areas at once.Can I apply Diclofenac Sodium Topical Gel, 1% without measuring it out on the dosing card first?No.Use the dosing card to make sure you are getting the correct amount of medicine.Can I use Diclofenac Sodium Topical Gel, 1% on my spine, hips, or shoulders?No.The use of Diclofenac Sodium Topical Gel, 1% on the spine, hips, and shoulders has not been studied.Can I take any other pain medications with Diclofenac Sodium Topical Gel, 1%?Ask your doctor or pharmacist before using Diclofenac Sodium Topical Gel, 1% if you are taking any other pain reliever or are planning on taking any other pain reliever, especially prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others).Can I take any other pain medications during the first 7 days I use Diclofenac Sodium Topical Gel, 1%?Taking other pain medications is generally not recommended. Speak with your doctor or pharmacist before taking other pain medications when using Diclofenac Sodium Topical Gel, 1%.How long can I use Diclofenac Sodium Topical Gel, 1%?Use Diclofenac Sodium Topical Gel, 1% 4 times a day every day for up to 21 days for treatment of arthritis pain or as directed by your doctor.Diclofenac Sodium Topical Gel, 1% should be part of an overall program for managing your arthritis pain. The program should also include activities such as appropriate movement or exercise, specific lifestyle changes, and weight maintenance. Regular visits and discussions with your doctor can help incorporate Diclofenac Sodium Topical Gel, 1% into a complete program to help manage your arthritis pain.What do I do if I get Diclofenac Sodium Topical Gel, 1% in my eyes?If eye contact occurs, rinse thoroughly with water and consult a doctor if irritation lasts more than an hour.How do I clean the dosing card?Wash the dosing card with water, and store dosing card and tube out of reach of children.What if I miss a dose of Diclofenac Sodium Topical Gel, 1%?If you forget to apply Diclofenac Sodium Topical Gel, 1% don’t double your dose. Just apply the next dose as scheduled.How should I store Diclofenac Sodium Topical Gel, 1%? •Store at 20-25°C (68-77°F). •Do not freeze Diclofenac Sodium Topical Gel, 1%. •Store the dosing card with your Diclofenac Sodium Topical Gel, 1%. •Keep out of reach of children.Additional Questions?Call 1-800-719-9260.

* Please review the disclaimer below.