Label: FLEXITOL FACE AND EYELID ECZEMA- oatmeal cream

  • NDC Code(s): 43251-4904-1
  • Packager: LaCorium Health USA Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated May 10, 2022

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  • 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)

    PRINCIPAL DISPLAY PANEL - 40 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    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)
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