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| Product NDC Code | 0067-8153 | ||||
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| Drug Name | Voltaren arthritis pain |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 855633, 855635 |
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| Application Number | NDA022122 | ||||
| Labeler Name | Haleon US Holdings LLC | ||||
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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)
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose Arthritis pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.Voltaren Arthritis Pain diclofenac sodium AMMONIA CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) COCOYL CAPRYLOCAPRATE ISOPROPYL ALCOHOL MINERAL OIL POLYOXYL 20 CETOSTEARYL ETHER PROPYLENE GLYCOL WATER DICLOFENAC SODIUM DICLOFENAC Voltaren Arthritis Pain diclofenac sodium Voltaren Arthritis Pain diclofenac sodium AMMONIA CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) COCOYL CAPRYLOCAPRATE ISOPROPYL ALCOHOL MINERAL OIL POLYOXYL 20 CETOSTEARYL ETHER PROPYLENE GLYCOL WATER DICLOFENAC SODIUM DICLOFENAC Voltaren Arthritis Pain diclofenac sodium AMMONIA CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) COCOYL CAPRYLOCAPRATE ISOPROPYL ALCOHOL MINERAL OIL POLYOXYL 20 CETOSTEARYL ETHER PROPYLENE GLYCOL WATER DICLOFENAC SODIUM DICLOFENAC
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel NDC 0067-8152-02 Voltaren ARTHRITIS PAIN diclofenac sodium topical gel, 1% (NSAID) - arthritis pain reliever Anti-Inflammatory For Daily Treatment of Arthritis Pain For external use only NET WT 1.76 oz (50 g) 1-855-297-3031 Made in Canada Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 Trademarks owned or licensed by GSK. ©2021 GSK or licensor. 30000000000042 Front Carton Voltaren Arthritis Pain 1.76 oz (50 g)
Principal Display Panel ORIGINAL PRESCRIPTION STRENGTH Voltaren ARTHRITIS PAIN diclofenac sodium topical gel, 1% (NSAID) - arthritis pain reliever ANTI-INFLAMMATORY For Daily Treatment of Arthritis Pain Medicated Gel Clinically Proven to Relieve Arthritis Pain NEW FLIP TOP CAP* *Cap for 150 g only For external use only TREATMENT AREAS Hand Wrist Elbow Foot Ankle Knee Not for use on any other body area (such as back, hip, or shoulder) Screw Cap Tamper evident statement: Do not use if safety seal on tube nozzle is broken or missing. Flip Cap Tamper evident statement: Do not use if plastic safety seals on sides of cap are broken or missing. 1-855-297-3031 Made in India Distributed by: Haleon, Warren, NJ 07059 Trademarks are owned by or licensed to the Haleon group of companies. @2023 Haleon group of companies or its licensor. 204419 Carton 204419 Voltaren Arthritis Pain 350g (12.34 oz) backercard
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Additional Information ORIGINAL PRESCRIPTION STRENGTH Medicated Gel Clinically Proven to Relieve Arthritis Pain TREATMENT AREAS Hand Wrist Elbow Foot Ankle Knee Not for use on any other body area (such as back, hip, or shoulder) TREATMENT AREAS Use Enclosed Dosing Card to Measure a Dose Voltaren ARTHRITIS PAIN diclofenac sodium topical gel, 1% (NSAID) – arthritis pain reliever Dosing Card (NOT ACTUAL SIZE) Read product User Guide before use Not for immediate pain relief Upper body dose 2.25 inches long (2 grams) Lower body dose 4.5 inches long (4 grams) How to Use For arthritis pain only Use 4 times a day May take up to 7 days to work for your arthritis pain For use on no more than 2 body areas Use up to 21 days unless directed by your doctor Tamper evident statement: Do not use if safety seal on tube nozzle is broken or missing.
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other drug
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Instructions for use
Information about safe handling and use of the drug product.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 Voltaren Arthritis Pain. The dosing card is re-usable.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-855-297-3031 www.voltarengel.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes, nose, or mouth if eye contact occurs, rinse thoroughly with water
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 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 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API