FDA.reportPublic FDA data

FDA label f973eae4-d0f4-4d17-8be4-121d3ffb77cf

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
09dd5cf9-788a-44ec-abb8-2abf9102b622
SPL ID
f973eae4-d0f4-4d17-8be4-121d3ffb77cf
Version
5
Effective date
2010-08-26
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:17:03

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. - Children under 2 years of age should be seen by a physician. - Initial exacerbation of symptoms may occur. - Use only if bottle seal is intact. - To avoid contamination, do not touch the tip of the container to any surface. - Use within 30 days of opening. Expiration date only refers to unopened bottle. - Replace cap tightly after every use. - Contact wearers: consult a physician prior to using. - The use of this container by more than one person may spread infection. - Keep this and all medicines out of the reach of children - If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children Keep this and all medicines out of the reach of children

Reported adverse events (FAERS/openFDA)#

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