Flexitol Face and Eyelid Eczema

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: Flexitol Face and Eyelid Eczema
Generic name: OATMEAL
Manufacturer: LaCorium Health USA Inc.
Product type: HUMAN OTC DRUG
SPL set ID: f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65
SPL ID: daa3258e-623a-4eb1-adae-94b38d034006
Version: 4
Effective date: 2025-12-02
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:38:28

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.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		Flexitol Face and Eyelid Eczema	openfda.brand_name
generic name		OATMEAL	openfda.generic_name
manufacturer name		LaCorium Health USA Inc.	openfda.manufacturer_name
ndc	package	43251-4904-1	openfda.package_ndc
ndc	product	43251-4904	openfda.product_ndc
ndc11	package	43251490401	derived:openfda.package_ndc
rxcui		1595494	openfda.rxcui
spl id		daa3258e-623a-4eb1-adae-94b38d034006	id
spl set id		f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65	set_id
unii		8PI54V663Y	openfda.unii

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 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 When using this product do not get into eyes Do not use on broken skin 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.