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西药 · 美国药品标签原文

双氯芬酸钠 · Diclofenac Sodium Topical 1%

DICLOFENAC SODIUM

Diclofenac Sodium Topical 1% · YYBA CORP。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

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spl product data elements

Diclofenac Sodium Topical 1% Diclofenac Sodium WATER CARBOMER HOMOPOLYMER TYPE C COCOYL CAPRYLOCAPRATE ISOPROPYL ALCOHOL MINERAL OIL POLYOXYL 20 CETOSTEARYL ETHER AMMONIA PROPYLENE GLYCOL DICLOFENAC SODIUM DICLOFENAC

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, KNEWW (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 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. SYMPROMS MAY INCLUDE: HIVES ASTHMA (WHEEZING) SKIN REDDENING BLISTERS FACIAL SWELLING SHOCK RASH IF ALLERGIC REACTION OCCURS, STOP USING 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 STEAROID DRUGS 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 INJUTIRES 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 IF 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.

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 AREA 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 border="0" width="100%"><tbody><tr><td>DAILY</td><td>PER DOSE</td></tr><tr><td><paragraph>FOR YOUR ARTHRITIS PAIN:</paragraph><list listType="unordered"><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><paragraph>USE ENCLOSED DOSING CARD TO MEASURE A DOSE</paragraph><list listType="unordered"><item>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>

储存 / Storage and handling

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.

辅料 / Inactive ingredients

INACTIVE INGREDIENTS CARBOMER HOMOPOLYMER TYPE C, COCOYL CAPRYLOCAPRATE, ISOPROPYL ALCOHOL, MINERAL OIL, POLYOXYL 20 CETOSTEARYL ETHER, PROPYLENE GLYCOL, PURIFIED WATER, AND STRONG AMMONIA SOLUTION.

questions

QUESTIONS OR COMMENTS? 1-866-933-6337

package label principal display panel

PDP DF1 DF2 P2 P3

来源、版本与许可

资料类型
美国药品标签原文
版本
4 / 20251110
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.
核对原始来源