DICLOFENAC SODIUM TOPICAL  1%- diclofenac sodium gel 
YYBA CORP

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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

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.

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.

DAILYPER 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:

OTHER 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.

QUESTIONS OR COMMENTS?

1-866-933-6337

PDP

DF1

DF2

P2

P3

DICLOFENAC SODIUM TOPICAL   1%
diclofenac sodium gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM1 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
AMMONIA (UNII: 5138Q19F1X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73581-104-151 in 1 BOX08/31/2023
1150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21098608/31/2023
Labeler - YYBA CORP (006339772)

Revised: 1/2024
Document Id: 0e135981-faca-f255-e063-6394a90ae356
Set id: 043df5d2-6f3e-311f-e063-6294a90a23d7
Version: 3
Effective Time: 20240103
 
YYBA CORP