FDA label b39ae8db-1283-41dc-b197-a838be5eabbf

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
b4b89923-ab66-41be-8e27-905573afa948
SPL ID
b39ae8db-1283-41dc-b197-a838be5eabbf
Version
4
Effective date
2025-01-17
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:36:58

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 For external use only. Do not apply to wounds or to damaged or irritated skin. When using this product you may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally diminishes. avoid contact with eyes. Do not get it on mucous membranes, into eyes, or on contact lenses. If this occurs, rinse the affected area thoroughly with water. do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise. do not apply heat to the treated areas immediately before or after use. do not tightly wrap or bandage the treated area. avoid inhaling airborne material from dried residue. This can result in coughing, sneezing, tearing, throat or respiratory irritation. Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. blistering occurs. difficulty breathing or swallowing occurs. severe burning persists. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.