FDA.reportPublic FDA data

Flexitol ® Face & Eyelid Eczema Cream

Manufacturer
LaCorium Health USA Inc. | Bentley Laboratories, LLC
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:25:31

Label at a glance#

ProductFlexitol Face and Eyelid Eczema
Active ingredientoatmeal
Label structure11 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak or sumac insect bites

Dosage and administration

apply generously to affected areas as needed

Storage and handling

Store between 50-86°F in a dry place

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

temporarily protects and helps relieve minor skin irritation and itching due to:

  • rashes
  • eczema
  • poison ivy, oak or sumac
  • insect bites

Warnings

WARNINGS SECTION

For external use only

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - WHEN USING SECTION

When using this product do not get into eyes

OTC - DO NOT USE SECTION

Do not use on broken skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply generously to affected areas as needed

Other Information

STORAGE AND HANDLING SECTION

Store between 50-86°F in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice powder, benzyl alcohol, butyrospermum parkii (shea) butter, caprylyl glycol, cetostearyl alcohol, decyl oleate, dehydroxanthan gum, glycerin, glyceryl stearate se, isopropyl myristate, water

Questions or Comments?

OTC - QUESTIONS SECTION

Call Toll Free 1-866-478-3338

usainfo@flexitol.com
www.flexitol.com

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
LaCorium Health USA Inc
801 Broad St, Suite 600
Chattanooga, TN 37402

PRINCIPAL DISPLAY PANEL - 40 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43251-4904-1

Flexitol™
SKIN THERAPY

FACE &
EYELID
ECZEMA
CREAM

SOOTHING
RELIEF FOR
DELICATE SKIN

CLINICALLY
TESTED*

Helps relieve red, itchy eczema
rashes on face and eyelids

With soothing Colloidal
Oatmeal 5%

Free from cortisone

Award
winning
formula

Skin
protectant

Hypoallergenic

Net Wt. 1.4 oz (40g)

PRINCIPAL DISPLAY PANEL - 40 g Tube Carton
PRINCIPAL DISPLAY PANEL - 40 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595494colloidal oatmeal 5 % Topical CreamPSN4
1595494colloidal oatmeal 50 MG/ML Topical CreamSCD4
1595494colloidal oatmeal 5 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeflexitol.com/offers/qr-scan-to-unlock/flexitol-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43251-4904-1Flexitol Face and Eyelid Eczema40 g in 1 TUBECREAM404
43251-4904-1Flexitol Face and Eyelid Eczema1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43251-4904-1GM - Gram43251-4904bedb3fa2-8dca-42f8-916c-eb1288c99e6812025-06-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43251-490443251-4904-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
oatmeal8PI54V663YACTIB
Water059QF0KO0RIACT
Cetostearyl Alcohol2DMT128M1SIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
Isopropyl Myristate0RE8K4LNJSIACT
DECYL OLEATEZGR06DO97TIACT
GlycerinPDC6A3C0OXIACT
BENZYL ALCOHOLLKG8494WBHIACT
SHEA BUTTERK49155WL9YIACT
Caprylyl glycol00YIU5438UIACT
Dehydroxanthan gum63ZP7I1BQOIACT
ALOE VERA LEAFZY81Z83H0XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flexitol Face and Eyelid EczemaOATMEALLaCorium Health USA Inc.f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee652025-12-02WarningsExact identifier
ndc (package): 43251-4904-1
ndc (product): 43251-4904
ndc11 (package): 43251490401
spl id: daa3258e-623a-4eb1-adae-94b38d034006
spl set id: f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65

Reported adverse events (FAERS/openFDA)#

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