Diclofenac Sodium by Two Hip Consulting, LLC DICLOFENAC SODIUM gel

Diclofenac Sodium by

Drug Labeling and Warnings

Diclofenac Sodium by is a Prescription medication manufactured, distributed, or labeled by Two Hip Consulting, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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.

OTHER SAFETY INFORMATION

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DICLOFENAC SODIUM 
diclofenac sodium gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 76074-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)	DICLOFENAC SODIUM	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHOXY PEG-40 (UNII: 6AXS45P1QU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76074-501-11	100 g in 1 TUBE; Type 0: Not a Combination Product	04/04/2016

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)