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.
Otc - Active Ingredient
(NSAID) - arthritis pain relieverActive ingredientDiclofenac sodium (NSAID*) 1%*nonsterodial anti-inflammatory drug
Otc - Purpose
PurposeArthritis pain reliever
Indications & Usage
- Usesfor 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 not pain relief in 7 days, stop use
WarningsFor 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 contain an NSAID, which may cause severe stomach bleeding. The chance is small but high 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 non-prescription 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 attach, heart failure, and stroke. These can be fatal. The rish is higher if you use more than directed or for longer than directed.
- For External Use OnlyAvoid contact with the eyes. If contact occurs, flush eyes with water
Otc - Do Not Use
- Do not useif you have ever had an allergic reaction to any other pain reliever or to a fever reducerfor strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.right before or after heart surgeryon more than 2 body areas at the same timein the eyes, nose or mouth
Otc - Ask Doctor
- Ask a doctor before use ifyou have problems or serious side effects from taking pain relievers or fever reducersstomach bleeding warning applies to you or you have a history of stomach prohlems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a strokeyou are taking a diureticyou are under the age of 18 years. It is not known if this drug works or is safe in children under age 18 years.
Otc - Ask Doctor/Pharmacist
- Ask a doctor or pharmacist before use if you areunder a doctor's care for any serious conditiontaking any other drug
Otc - When Using
- When using this productavoid contact with eyes, nose, or mouthif eye contact occurs, rinse thoroughly with water
Otc - Stop Use
- Stop use and ask a doctor ifpain gets worse or last more than 21 daysredness or swelling is present in the painful areafever occursskin irritation occursany new symptoms appear. These could be signs of a serious condition.you experience any of the following signs of stomach bleedingfeel fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get betteryou have symptoms of heat problems or strokechest paintrouble breathingleg swellingweakness in one part or side of bodyslurred speech
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feedingask a health care 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.
Otc - Keep Out Of Reach Of Children
Keep our of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- DirectionsUse 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.Daily For arthritis pain:Use 4 times per day every day
- Do not use on more than 2 body areas at the same time
- Per Dose (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 the 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% Arthritis Pain. The dosing card is re-usable.
Other Safety Information
- Other InformationStore at 20-25°C (68°F - 77°F). Keep from freezing.read all product information before using. Keep the dossing card, the carton and accomanying User guide for important information.
Inactive ingredientsCarbomer homopolymer Type C, cocoyl caprylocaprate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution.
Otc - Questions
Questions and comments 1-866-747-7365
Isopropyl Alcohol, 70% v/v
- Antiseptic cleanserKills harmful bacteria and germsFirst aid help prevent infection
Do Not Use
- With electrocautery proceduresIn the eyes
Stop Use And Ask A Doctor If
- Irritation and redness developsIf condition persists for more than 72 hours, consult a physician
Discontinue Use And Consult A Healthcare Practitioner If
Keep Out Of Reach Of Children
- If swallowed, get medical help or contact a Poison Control Center right away
- Use as part of your daily cleansing routineMay be covered with a sterile bandage
- Store at room temperature 15°-30°C (59°-86°F)Avoid excessive heat
How Supplied/Storage And Handling
Diclofenac sodium topical gel, 1% is available in tubes containing 100 g of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%).100 g tubeNDC 70512-0106-10
Storage And Handling
StorageStore at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your diclofenac sodium topical gel.
NDC: 81877-512-10DICLOPREP-100Topical KitDiclofenac Sodium Topical Gel, 1 %(100 g)Sterile Alcohol Prep Pads(Isopropyl alcohol, 100 count)See enclosed insert(s) for full prescribing informationUsual Dosage: See package insert for dosage and full prescribing information.Storage: Store at 20° to 25°C (68°-77°F) [see USP Controlled Room Temperature].Keep this and all medication out of reach of children.Packaged For: Forreal Pharmaceuticals, LLCRoyal Oak, MI 48067Questions or Comments please call 877-367-3250Forreal Pharmaceuticals LLC
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