Indications & Usage
INDICATIONS: For the topical treatmentof active keratosis.
Diclofenac Sodium
FDA Label NDC 76074-501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Two Hip Consulting, Llc for the product Diclofenac Sodium (NDC 76074-501). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage, inactive ingredients, usual adult dosage, warning, other safety information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
* Please review the disclaimer below.
