Arthritis Pain Reliever
Diclofenac Sodium
Harris Teeter, Llc
Human Otc Drug
NDC 69256-012Arthritis Pain Reliever also known as Diclofenac Sodium is a human otc drug labeled by 'Harris Teeter, Llc'. National Drug Code (NDC) number for Arthritis Pain Reliever is 69256-012. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Arthritis Pain Reliever drug includes Diclofenac Sodium - 10 mg/g . The currest status of Arthritis Pain Reliever drug is Active.
Drug Information:
| Drug NDC: | 69256-012 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Arthritis Pain Reliever |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Diclofenac Sodium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Harris Teeter, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DICLOFENAC SODIUM - 10 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 29 Jan, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA208077 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Harris Teeter, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 855633
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0072036735287
|
| UPC stands for Universal Product Code. |
| UNII: | QTG126297Q
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Anti-Inflammatory Agents
Non-Steroidal [CS]
Cyclooxygenase Inhibitors [MoA]
Decreased Prostaglandin Production [PE]
Nonsteroidal Anti-inflammatory Drug [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69256-012-17 | 1 TUBE in 1 CARTON (69256-012-17) / 50 g in 1 TUBE | 29 Jan, 2021 | N/A | No |
| 69256-012-35 | 1 TUBE in 1 CARTON (69256-012-35) / 100 g in 1 TUBE | 29 Jan, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose arthritis pain reliever
Product Elements:
Arthritis pain reliever diclofenac sodium diclofenac sodium diclofenac carbomer homopolymer type c coco-caprylate/caprate isopropyl alcohol mineral oil polyoxyl 20 cetostearyl ether propylene glycol water ammonia
Indications and 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
Warnings:
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, excep
Read more...t 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 the age of 18 years. it is not known if this drug works or is safe in children under the age of 18 years. ask a doctor or pharmacist before use if under a doctors 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 of 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 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 (1-800-222-1222) right away
Do Not Use:
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 the age of 18 years. it is not known if this drug works or is safe in children under the age of 18 years. ask a doctor or pharmacist before use if under a doctors 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 of 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 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 (1-800-222-1222) right away
When Using:
When using this product avoid contact with eyes, nose, or mouth if eye contact occurs, rinse thoroughly with water
Dosage and 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) 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 areas as any other product do not apply with external heat such as a heating pad do not apply a bandage over the treated area store enclosed dosing card with your diclofenac sodium topical gel, 1%. the dosing card is re-usable.
Stop Use:
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 of side of body slurred speech
Package Label Principal Display Panel:
Principal display panel compare to the active ingredient in voltaren® arthritis pain topical gel diclofenac sodium topical gel, 1% arthritis pain reliever (nsaid) original prescription strength medicated gel clinically proven to relieve arthritis pain for daily treatment of arthritis pain anti-inflammatory for external use only net wt oz (g) this product is not manufactured or distributed by glaxosmithkline consumer healthcare holdings (us) llc, distributor of voltaren® arthritis pain topical gel. tamper evident statement: do not use if foil seal on tube opening is broken or missing. distributed by: harris teeter, llc matthews, nc 28105
Package label harris teeter arthritis pain reliever diclofenac sodium (nsaid*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug
Further Questions:
Questions or comments? call 1-877-753-3935 monday-friday 9 am- 5 pm est