FDA.reportPublic FDA data

FDA label b4e66f01-8994-4e43-89df-ab168c89d381

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
5c6d7fb2-a6bc-491c-b9bd-9f80fd54fa7c
SPL ID
b4e66f01-8994-4e43-89df-ab168c89d381
Version
4
Effective date
2021-11-16
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:50:46

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For external use only Do not use • near eyes • inside nose, mouth, or vagina • on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas. Ask a doctor before use if you are • allergic to ragweed. May cause breathing difficulty or an asthmatic attack. When using this product • keep eyes tightly closed and protect eyes with a washcloth or towel • if product gets in eyes, flush with water right away • scalp itching or redness may occur Stop use and ask a doctor if • breathing difficulty occurs • eye irritation occurs • skin or scalp irritation continues or infection occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

warnings

Warnings For external use only. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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