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YYBA (as PLD) - Welmate Diclofenac Sodium Topical Gel, 1% (73581-104)


Active ingredient

DICLOFENAC SODIUM (NSAID*) 1% (EQUIVALENT TO 0.93% DICLOFENAC)

*NONSTEROIDAL ANTI-INFLAMMATORY DRUG


Purpose

ARTHRITIS PAIN RELIEVER


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.

Warnings

FOR EXTERNAL USE ONLY.

ALLERGY ALERT: DICLOFENAC MAY CAUSE A SEVERE ALLERGIC REACTION, ESPECIALLY IN PEOPLE ALLERGIC TO ASPIRIN. SYMPROMS MAY INCLUDE:

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

STOMACH BLEEDING WARNING: THIS PRODUCT CONTAINS AN NSAID, WHICH MAY CAUSE SEVERE STOMACH BLEEDING. THE CHANCE IS SMALL BUT HIGHER IF YOU

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

ASK A DOCTOR BEFORE USE IF

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

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.

  • HIVES
  • ASTHMA (WHEEZING)
  • SKIN REDDENING
  • BLISTERS
  • FACIAL SWELLING
  • SHOCK
  • RASH

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER (1-800-222-1222) RIGHT AWAY.


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.

READ THE ENCLOSED USER GUIDE FOR COMPLETE INSTRUCTIONS:

DAILYPER DOSE
FOR YOUR ARTHRITIS PAIN:USE 4 TIMES PER DAY EVERY DAYDO NOT USE ON MORE THAN 2 BODY AREAS AT THE SAME TIMEUSE ENCLOSED DOSING CARD TO MEASURE A DOSEFOR 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)
  • 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.

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.

INACTIVE INGREDIENTS

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


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL