DICLOFENAC SODIUM- diclofenac sodium gel 
Two Hip Consulting, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INDICATIONS: For the topical treatmentof active keratosis.

INACTIVE INGREDIENTS

HYALURONATE SODIU, BENZYL ALCOHOL, POLYETHYLENE GLYCOL MONOMETHYL ETHER, PURIFIED WATER.

USUAL ADULT DOSAGE

0.5G OF GEL (SIZE OF A PEA APPLIED TO AFFECTED AREA AND SMOOTHED INTO SKIN GENTLY, OR AS DIRECTED BY YOUR PHYSICIAN. THE USUAL DURATION OF THERAPY IS FROM 60 TO 90 DAYS.

WARNING

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Please see package insert for full prescribing information. Store at 20 to 25 degrees C (68 to 77 degrees F): excursions permitted to 15 – 30 C (59 – 86 degrees F) Protect from heat. Avoid freezing. See crimp of tube and/or carton for lot number and expiration date.

Medi-Sulting-Diclofenac Label Rx NDC-1

DICLOFENAC SODIUM 
diclofenac sodium gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76074-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHOXY PEG-40 (UNII: 6AXS45P1QU)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76074-501-11100 g in 1 TUBE; Type 0: Not a Combination Product04/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/25/2016
Labeler - Two Hip Consulting, LLC (965352896)
Registrant - Two Hip Consulting, LLC (965352896)

Revised: 2/2019
Document Id: b4e24953-24ad-4bbd-8ed0-21484936a843
Set id: 44b76125-05bd-42fe-a3e8-1d8ec39984e5
Version: 4
Effective Time: 20190206
 
Two Hip Consulting, LLC