FLEXITOL FACE AND EYELID ECZEMA- oatmeal cream 
LaCorium Health USA Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Flexitol® Face & Eyelid Eczema Cream

Drug Facts

Active ingredient

Colloidal Oatmeal 5%

Purpose

Skin protectant

Uses

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

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

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)

PRINCIPAL DISPLAY PANEL - 40 g Tube Carton
FLEXITOL FACE AND EYELID ECZEMA 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-4904
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
oatmeal (UNII: 8PI54V663Y) (oatmeal - UNII:8PI54V663Y) oatmeal50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43251-4904-11 in 1 CARTON01/01/2022
140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2022
Labeler - LaCorium Health USA Inc. (111254392)
Establishment
NameAddressID/FEIBusiness Operations
Ross Laboratories Aust Pty Ltd753529114MANUFACTURE(43251-4904) , LABEL(43251-4904) , ANALYSIS(43251-4904) , PACK(43251-4904)

Revised: 5/2022
Document Id: a4baec69-f891-4963-bb19-54396e515aef
Set id: f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65
Version: 2
Effective Time: 20220510
 
LaCorium Health USA Inc.