Voltaren Arthritis Pain
Diclofenac Sodium
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0067-8152Voltaren Arthritis Pain also known as Diclofenac Sodium is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Voltaren Arthritis Pain is 0067-8152. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Voltaren Arthritis Pain drug includes Diclofenac Sodium - 10 mg/g . The currest status of Voltaren Arthritis Pain drug is Active.
Drug Information:
| Drug NDC: | 0067-8152 |
| 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: | Voltaren Arthritis Pain |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Voltaren |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Arthritis Pain |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Glaxosmithkline Consumer Healthcare Holdings (us) 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: | NDA |
| 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: | 13 May, 2020 |
| 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: | NDA022122 |
| 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: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 855633
855635
|
| 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. |
| 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 |
|---|
| 0067-8152-01 | 1 TUBE in 1 CARTON (0067-8152-01) / 20 g in 1 TUBE | 13 May, 2020 | N/A | No |
| 0067-8152-02 | 1 TUBE in 1 CARTON (0067-8152-02) / 50 g in 1 TUBE | 13 May, 2020 | N/A | No |
| 0067-8152-03 | 1 TUBE in 1 CARTON (0067-8152-03) / 100 g in 1 TUBE | 13 May, 2020 | N/A | No |
| 0067-8152-04 | 1 TUBE in 1 CARTON (0067-8152-04) / 150 g in 1 TUBE | 13 May, 2020 | N/A | No |
| 0067-8152-08 | 2 TUBE in 1 CARTON (0067-8152-08) / 100 g in 1 TUBE | 31 May, 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:
Voltaren arthritis pain diclofenac sodium diclofenac sodium diclofenac ammonia carbomer homopolymer type c (allyl pentaerythritol crosslinked) cocoyl caprylocaprate isopropyl alcohol mineral oil polyoxyl 20 cetostearyl ether propylene glycol water voltaren arthritis pain diclofenac sodium voltaren arthritis pain diclofenac sodium diclofenac sodium diclofenac ammonia carbomer homopolymer type c (allyl pentaerythritol crosslinked) cocoyl caprylocaprate isopropyl alcohol mineral oil polyoxyl 20 cetostearyl ether propylene glycol water voltaren arthritis pain diclofenac sodium diclofenac sodium diclofenac ammonia carbomer homopolymer type c (allyl pentaerythritol crosslinked) cocoyl caprylocaprate isopropyl alcohol mineral oil polyoxyl 20 cetostearyl ether propylene glycol water
Indications and Usage:
Uses for the temporary relief of arthritis pain only in the following areas: o hand, wrist, elbow (upper body areas) o 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
Read more... 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 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 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: o feel faint o have bloody or black stools o vomit blood o have stomach pain that does not get better you have symptoms of heart problems or stroke: o chest pain o trouble breathing o leg swelling o weakness in one part or side of body o slurred speech if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use diclofenac at 20 weeks or later in 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.
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 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 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: o feel faint o have bloody or black stools o vomit blood o have stomach pain that does not get better you have symptoms of heart problems or stroke: o chest pain o trouble breathing o leg swelling o weakness in one part or side of body o slurred speech if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use diclofenac at 20 weeks or later in 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.
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)
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: o feel faint o have bloody or black stools o vomit blood o have stomach pain that does not get better you have symptoms of heart problems or stroke: o chest pain o trouble breathing o leg swelling o weakness in one part or side of body o slurred speech
Package Label Principal Display Panel:
Principal display panel ndc 0067-8152-03 voltaren arthritis pain diclofenac sodium topical gel, 1% (nsaid) - arthritis pain reliever original prescription strength for daily treatment of arthritis pain anti-inflammatory net wt 3.53 oz (100 g) for external use only 1-855-297-3031 made in canada distributed by: gsk consumer healthcare , warren, nj 07059 trademarks are owned by or licensed to the gsk group of companies. ©2021 gsk or licensor. npa004453 voltaren arthritis pain 100g carton
Principal display panel ndc 0067-8153-01 voltaren arthritis pain diclofenac sodium topical gel, 1% (nsaid) - arthritis pain reliever original prescription strength medicated gel clinically proven to relieve arthritis pain for daily treatment of arthritis pain anti-inflammatory treatment areas hand wrist elbow foot ankle knee not for use on any other body area (such as back, hip, or shoulder) easy twist cap* *cap for 150 g only for external use only net wt 2 x 150 g + 50 g (350 g) (12.34 oz) 1-855-297-3031 made in canada distributed by: gsk consumer healthcare , warren, nj 07059 trademarks are owned by or licensed to the gsk group of companies. ©2021 gsk or licensor. 1000782 voltaren arthritis pain 350g backercard
Further Questions:
Questions or comments? 1-855-297-3031www.voltarengel.com