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spl product data elements
Diclofenac sodium Diclofenac sodium DICLOFENAC SODIUM DICLOFENAC CARBOMER HOMOPOLYMER TYPE C COCO-CAPRYLATE/CAPRATE ISOPROPYL ALCOHOL MINERAL OIL POLYOXYL 20 CETOSTEARYL ETHER PROPYLENE GLYCOL WATER AMMONIA
活性成分 / Active ingredient
Active ingredient Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) * nonsteroidal anti-inflammatory drug
用途 / Purpose
Purpose Arthritis Pain Reliever
适应证 / Indications and 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 no pain relief in 7 days, stop use
警告 / 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 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 the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years. Ask a doctor or pharmacist before use if 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 of side of body slurred speech If pregnant or breast-feeding, ask a health professional before use. It is especially important to not 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 (1-800-222-1222) right away
禁用事项 / 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
咨询医生 / Ask a doctor
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 the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years.
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if under a doctor’s care for any serious condition taking any other drug
使用中 / When using
When using this product avoid contact with eyes, nose, or mouth if eye contact occurs, rinse thoroughly with water
停用事项 / 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: 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 of side of body slurred speech
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important to not 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.
儿童安全 / Keep out of reach of children
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
用法用量原文 / 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) 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 areas as any other product do not apply with external heat such as a heating pad do not apply a bandage over the treated area store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. The dosing card is re-usable.
dosage and administration table
<table width="404.4px"><col/><col/><tbody><tr><td styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold"> Daily</content></td><td styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold"> Per Dose</content></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold"> For your arthritis pain:</content></paragraph><list listType="unordered" styleCode="Disk"><item>Use 4 times per day every day</item><item>Do not use on more than 2 body areas at the same time</item></list></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> <content styleCode="bold">Use ENCLOSED DOSING CARD to measure a dose</content></paragraph><list listType="unordered" styleCode="Disk"><item><content styleCode="bold"> </content>For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams)</item><item>For each lower body area (foot, ankle, or knee) – Squeeze out 4.5 inches (4 grams) </item></list></td></tr></tbody></table>
spl unclassified section
Other information store at 20° to 25°C (68° to 77°F). Keep from freezing. read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information
辅料 / Inactive ingredients
Inactive ingredients carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution
questions
Questions or comments? Call 1-877-753-3935 Monday-Friday 9 AM- 5 PM EST
用药指南 / Medication guide
Medguide Use enclosed dosing card to measure a dose Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain reliever Upper body dose 2.25 inches long (2 grams) Dosing Card (NOT ACTUAL SIZE) Read product User Guide before use Not for immediate pain relief 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
spl medguide table
<table><col/><col/><col/><col/><tbody><tr><td><content styleCode="bold">Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain reliever</content></td><td> </td><td> </td><td> </td></tr><tr><td><content styleCode="bold">Upper body dose</content> 2.25 inches long (2 grams) </td><td><paragraph><content styleCode="bold">Dosing Card (NOT ACTUAL SIZE) </content></paragraph><paragraph><content styleCode="bold">Read product User Guide before use</content></paragraph><paragraph><content styleCode="bold">Not for immediate pain relief</content></paragraph></td><td> </td><td> </td></tr><tr><td><content styleCode="bold">Lower body dose</content> 4.5 inches long (4 grams)</td><td> </td><td> </td><td> </td></tr></tbody></table>
package label principal display panel
Principal Display Panel COMPARE TO VOLTAREN® ARTHRITIS PAIN TOPICAL GEL active ingredient† Original Prescription Strength Arthritis Pain Reliever Diclogenac Sodium Topical Gel, 1% (NSAID) Arthritis Pain Reliever Medicated Gel Clinically Proven To Relieve Arthritis Pain For Daily Treatment of Arthritis Pain Anti-Inflammatory For External Use Only NET WT OZ (g) † This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Voltaren® Arthritis Pain Topical Gel. TAMPER EVIDENT STATEMENT: DO NOT USE IF FOIL SEAL ON TUBE OPENING IS BROKEN OR MISSING. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017
Package Label LEADER Arthritis Pain Reliever Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 6 / 20260526
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

