FLEXITOL FACE AND EYELID ECZEMA- oatmeal cream

Flexitol Face and Eyelid Eczema by

Drug Labeling and Warnings

Flexitol Face and Eyelid Eczema by is a Otc medication manufactured, distributed, or labeled by LaCorium Health USA Inc., Ross Laboratories Aust Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Colloidal Oatmeal 5%

Purpose

Skin protectant

Uses

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

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

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.

Directions

apply generously to affected areas as needed

Other Information

Store between 50-86°F in a dry place

Inactive ingredients

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?

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

NDC: 43251-4904-1

Flexitol®

FACE &
EYELID
ECZEMA
CREAM

SOOTHING RELIEF
FOR DELICATE SKIN

HELPS RELIEVE RED, ITCHY,
ECZEMA RASHES ON FACE
& EYELIDS

WITH SOOTHING COLLOIDAL
OATMEAL 5%

FREE FROM CORTISONE

SKIN PROTECTANT

HYPOALLERGENIC

Proud Supporter
eczema
association
australia
eaa

Net Wt. 1.4 oz (40g)

INGREDIENTS AND APPEARANCE

FLEXITOL FACE AND EYELID ECZEMA 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43251-4904
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
oatmeal (UNII: 8PI54V663Y) (oatmeal - UNII:8PI54V663Y)	oatmeal	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
DECYL OLEATE (UNII: ZGR06DO97T)
Glycerin (UNII: PDC6A3C0OX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SHEA BUTTER (UNII: K49155WL9Y)
Caprylyl glycol (UNII: 00YIU5438U)
Dehydroxanthan gum (UNII: 63ZP7I1BQO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-4904-1	1 in 1 CARTON	01/01/2022
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M016	01/01/2022

Labeler - LaCorium Health USA Inc. (111254392)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	MANUFACTURE(43251-4904)