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| Product NDC Code | 41167-0573 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Aspercreme arthritis |
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| Type | Brand | ||||||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| RxCUI drug identifier | 855633 | ||||||||
| Application Number | ANDA211253 | ||||||||
| Labeler Name | Chattem, Inc. | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient
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) 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 Aspercreme Arthritis Pain. The dosing card is re-usable.
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.Use s ■ 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 Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)......................... Arthritis pain reliever *nonsteroidal anti-inflammatory drug
Spl product data elements
Usually a list of ingredients in a drug product.Aspercreme Arthritis Diclofenac Sodium DICLOFENAC SODIUM DICLOFENAC CARBOMER HOMOPOLYMER TYPE C COCOYL CAPRYLOCAPRATE ISOPROPYL ALCOHOL MINERAL OIL POLYOXYL 20 CETOSTEARYL ETHER PROPYLENE GLYCOL WATER AMMONIA
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 A spercreme ARTHRITIS PAIN NET WT 3.53 OZ (100g) PRINCIPAL DISPLAY PANEL Aspercreme ARTHRITIS PAIN NET WT 3.53 OZ (100g)
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.ASPERCREME ARTHRIT I S PAIN Drug Facts
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.
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
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 (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-866-844-2798 or visit www. a spercreme.com Keep carton as it contains important information .
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 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
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 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).
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