Prescribing information (package insert) - Diclofenac Sodium
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.
About this document
Source: FDA drug labeling via NLM DailyMed
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Drug information for Diclofenac Sodium
| Rx or OTC |
Prescription (Rx)?
- This drug is available only with a prescription from a licensed healthcare provider.
- Rx
|
| Drug class |
Nonsteroidal Anti-inflammatory Drug |
| Active ingredient |
Diclofenac sodium 3 g/100 g
|
| Dosage form |
Gel |
| Route |
Topical |
| Marketing status |
not in the current FDA NDC Directory |
| Company (applicant) |
Two Hip Consulting, LLC |
| FDA approval |
UNAPPROVED DRUG OTHERUnapproved drug
|
| Manufacturers |
2 labelers list this drug on DailyMed |
| Packages (NDC) |
| Package |
|
3 g/100 g – 100 g in 1 tube
NDC 76074-501-11
|
|
Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.
