FDA label b474ba75-9596-4b42-b893-a0a5ed985040

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
2b4b3e06-d090-499a-a1a6-704f3f2c0254
SPL ID
b474ba75-9596-4b42-b893-a0a5ed985040
Version
4
Effective date
2025-07-22
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 02:54:02

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 use • on children under 2 months of age • near the eyes • inside the nose, ear, mouth, or vagina • on lice in eyebrows or eyelashes. See your doctor. Ask a doctor before use if you are • allergic to ragweed. May cause breathing difficulty or an asthmatic episode. When using this product • keep eyes tightly closed and protect eyes with a washcloth or towel • if product gets into the eyes, immediately flush with large amounts of water • scalp itching or redness may occur Stop use and see a doctor if • breathing difficulty occurs • eye irritation occurs • skin or scalp irritation continues or infection occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

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