Label: FLEXITOL ECZEMA AND DERMATITIS- oatmeal cream

  • NDC Code(s): 43251-9020-1, 43251-9020-2
  • Packager: LaCorium Health USA Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Colloidal Oatmeal 5%

  • Purpose

    Skin protectant

  • Uses

    temporarily protects and relieves minor skin irritation and itching due to:

    • eczema
    • dermatitis
    • rashes
  • 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
    • If contact occurs, rinse eyes thoroughly with water.
    • 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 as needed to affected skin 2-3 times a day
    • Smooth in gently
    • The smallest effective dose should be used
    • Patch test recommended on sensitive skin
    • Suitable for use on children 2 years of age and older
  • Other Information

    Store between 50-86°F in a dry place

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice powder, calendula officinalis flower extract, cetearyl alcohol, ceteth-20, dimethicone 100, edetate disodium, glycerin, glyceryl caprylate, glyceryl stearate, hydroxyacetophenone, isopropyl myristate, mineral oil light, phenoxyethanol, sodium benzoate, sodium stearoyl glutamate, triethanolamine, water

  • Questions or Comments?

    Call Toll Free 1-877-687-2542

    usainfo@flexitol.com
    www.flexitol.com

  • PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

    NDC: 43251-9020-1

    Flexitol®

    ECZEMA
    & DERMATITIS
    CREAM

    RASH RELIEF

    RELIEVES RASH, IRRITATION,
    ITCHING AND REDNESS

    FREE FROM CORTISONE,
    COAL AND PINE TAR

    COLLOIDAL OATMEAL 5%
    SKIN PROTECTANT CREAM

    SUITABLE FOR
    CHILDREN

    Proud Supporter
    eczema
    association
    australasia
    eaa

    Net Wt. 2.11 oz (60 g)

    PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    FLEXITOL ECZEMA AND DERMATITIS 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-9020
    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
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Water (UNII: 059QF0KO0R)  
    Carbomer Interpolymer type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Ceteth-20 (UNII: I835H2IHHX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glyceryl Monocaprylate (UNII: TM2TZD4G4A)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydroxyacetophenone (UNII: G1L3HT4CMH)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Trolamine (UNII: 9O3K93S3TK)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43251-9020-11 in 1 CARTON01/10/2020
    156 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:43251-9020-21 g in 1 PACKET; Type 0: Not a Combination Product01/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01601/10/2020
    Labeler - LaCorium Health USA Inc (111254392)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753MANUFACTURE(43251-9020)
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