DicloPrep-100 diclofenac sodium, isopropyl alcohol Diclofenac sodium diclofenac sodium 1% DICLOFENAC SODIUM DICLOFENAC POLYOXYL 20 CETOSTEARYL ETHER PROPYLENE GLYCOL AMMONIA CARBOMER HOMOPOLYMER TYPE C COCO-CAPRYLATE/CAPRATE ISOPROPYL ALCOHOL MINERAL OIL WATER white to off-white
Drug Facts
Composition & Profile
Identifiers & Packaging
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 tube NDC 70512-0106-10 Storage Store 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.; DicloPrep-100 NDC: 81877-512-10 DICLOPREP-100 Topical Kit Diclofenac Sodium Topical Gel, 1 % (100 g) Sterile Alcohol Prep Pads (Isopropyl alcohol, 100 count) See enclosed insert(s) for full prescribing information Usual 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, LLC Royal Oak, MI 48067 Questions or Comments please call 877-367-3250 Forreal Pharmaceuticals LLC label
- 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 tube NDC 70512-0106-10 Storage Store 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.
- DicloPrep-100 NDC: 81877-512-10 DICLOPREP-100 Topical Kit Diclofenac Sodium Topical Gel, 1 % (100 g) Sterile Alcohol Prep Pads (Isopropyl alcohol, 100 count) See enclosed insert(s) for full prescribing information Usual 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, LLC Royal Oak, MI 48067 Questions or Comments please call 877-367-3250 Forreal Pharmaceuticals LLC label
Overview
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 not pain relief in 7 days, stop use Uses Antiseptic cleanser Kills harmful bacteria and germs First aid help prevent infection
Indications & 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 not pain relief in 7 days, stop use Uses Antiseptic cleanser Kills harmful bacteria and germs First aid help prevent infection
Dosage & 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 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. Directions Use as part of your daily cleansing routine May be covered with a sterile bandage
Warnings & Precautions
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 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 directed Heart 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. Warnings For External Use Only Avoid contact with the eyes. If contact occurs, flush eyes with water Flammable, keep away from fire or flame. Do not use With electrocautery procedures In the eyes Stop use and ask a doctor if Irritation and redness develops If condition persists for more than 72 hours, consult a physician Discontinue use and consult a healthcare practitioner if Irritation develops Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away
Purpose
Purpose Arthritis pain reliever Purpose Antiseptic
Do Not Use
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 Do not use With electrocautery procedures In the eyes
When Using
When using this product avoid contact with eyes, nose, or mouth if eye contact occurs, rinse thoroughly with water
Stop Use & Ask a Doctor
Stop use and ask a doctor if pain gets worse or last 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 heat problems or stroke chest pain trouble breathing leg swelling weakness in one part or side of body slurred speech Stop use and ask a doctor if Irritation and redness develops If condition persists for more than 72 hours, consult a physician
Keep Out of Reach of Children
Keep our of reach of children If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away
Storage & Handling
Other Information Store at room temperature 15°-30°C (59°-86°F) Avoid excessive heat Storage Store 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.
Questions
Questions and comments 1-866-747-7365
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