FDA label 57ca6e1a-ffff-4f7c-ae6a-369586d383ad

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
cc8a504a-f427-4382-b73a-6a044d2877d6
SPL ID
57ca6e1a-ffff-4f7c-ae6a-369586d383ad
Version
4
Effective date
2018-01-09
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:33:07

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 side effects occur 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.

Reported adverse events (FAERS/openFDA)#

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