Diclofenac Sodium Topical 1% 1 mg/100g

Diclofenac Sodium · GEL · YYBA CORP

No Recall History

Plain English

Diclofenac Sodium Topical 1% is a gel containing diclofenac sodium at 1 mg/100g, taken topical. Manufactured by YYBA CORP.

Key Facts

Brand Name: Diclofenac Sodium Topical 1%
Generic Name: Diclofenac Sodium
NDC Code (Product): 73581-104
Manufacturer: YYBA CORP
Strength: 1 mg/100g
Dosage Form: GEL
Route: TOPICAL
Marketing Status
Application #: ANDA210986
Marketing Start: 08/31/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective7,500 reports

pain7,261 reports

fatigue6,863 reports

rheumatoid arthritis6,258 reports

rash5,933 reports

abdominal discomfort5,905 reports

systemic lupus erythematosus5,737 reports

alopecia5,681 reports

pemphigus5,566 reports

glossodynia5,565 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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.

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 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.

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 HA…

Frequently Asked Questions

What is Diclofenac Sodium Topical 1% used for?

Diclofenac Sodium Topical 1% contains Diclofenac Sodium. It is a gel taken topical. Consult your doctor for specific uses.

Is Diclofenac Sodium Topical 1% a controlled substance?

Diclofenac Sodium Topical 1% is not classified as a controlled substance by the DEA.

What is the generic name for Diclofenac Sodium Topical 1%?

The generic name for Diclofenac Sodium Topical 1% is Diclofenac Sodium. There are 12 other brand versions of Diclofenac Sodium.

What is the NDC code for Diclofenac Sodium Topical 1% 1 mg/100g?

The NDC (National Drug Code) for Diclofenac Sodium Topical 1% 1 mg/100g is 73581-104, listed by YYBA CORP.

Product NDC

73581-104

Package NDC

73581-104-10

Other Diclofenac Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)