Diclofenac Sodium

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.

INDICATIONS: For the topical treatmentof active keratosis.

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
(click image for full-size original)

DICLOFENAC SODIUM
diclofenac sodium gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76074-501
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
BENZYL ALCOHOL
METHOXY PEG-40
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76074-501-11 100 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/25/2016
Labeler — Two Hip Consulting, LLC (965352896)
Registrant — Two Hip Consulting, LLC (965352896)

Revised: 02/2019 Two Hip Consulting, LLC

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