Home FDA labels 2dc4926b-1c54-4e3d-82af-e4ae8823e7fd FDA label 2dc4926b-1c54-4e3d-82af-e4ae8823e7fd openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
SPL set ID f4b6c5d8-615c-47d6-8ad9-523c7ab146af
SPL ID 2dc4926b-1c54-4e3d-82af-e4ae8823e7fd
Version 10
Effective date 2013-04-25
Source export date 2026-08-08
Source partition 3
Source file https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-08-08/fb2175520ba436c0a81d623fd2a743c12c69c2188c898ffb9cc87c6b64d4a6cd/drug-label-0003-of-0014.json.zip
Source manifest SHA-256 b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run 20260810T161303Z
Imported at 2026-08-10 16:32:49 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings WARNINGS Naftin ® Cream and Gel, 1% are for topical use only and not for ophthalmic use.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS During clinical trials with Naftin ® Cream, 1%, the incidence of adverse reactions was as follows: burning/stinging (6%), dryness (3%), erythema (2%), itching (2%), local irritation (2%). During clinical trials with Naftin ® Gel, 1%. the incidence of adverse reactions was as follows: burning Istinging (5.0%), itching (1.0%), erythema (0.5%), rash (0.5%), skin tenderness (0.5%).