FDA label 0b57d8e4-f9ea-2401-e063-6394a90a31dc

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: 7836127f-d472-4aac-9443-10f56d735d1f
SPL ID: 0b57d8e4-f9ea-2401-e063-6394a90a31dc
Version: 5
Effective date: 2023-11-29
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 02:29:44

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		0b57d8e4-f9ea-2401-e063-6394a90a31dc	id
spl set id		7836127f-d472-4aac-9443-10f56d735d1f	set_id

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 for diaper rash on children under 2 years of age unless directed by doctor When using this product avoid contact with the eyes Stop use immediately and ask a doctor if irritation occurs there is no improvement within 4 weeks If pregnant or breast-feeding, ask a health rofessional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 800.222.1222

Reported adverse events (FAERS/openFDA)#

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