Home FDA labels 4c9bac93-a769-93fb-e063-6294a90ab661 Prequel Anti-Itch Solution Medicated Calming 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)
Brand name Prequel Anti-Itch Solution Medicated Calming
Generic name MEDICATED CALMING LOTION
Manufacturer The Center Brands, LLC
Product type HUMAN OTC DRUG
SPL set ID 419fa45b-992b-676e-e063-6394a90add81
SPL ID 4c9bac93-a769-93fb-e063-6294a90ab661
Version 3
Effective date 2026-03-09
Source export date 2026-10-12
Source partition 1
Source file https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:25:08 Harmonized routes table Harmonized routes TOPICAL
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 · 11 matching rows.
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 Fox external use only. When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days If swallowed, get medial 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.