Label: EXTRA STRENGTH BODY- colloidal oatmeal cream

  • NDC Code(s): 54291-038-01
  • Packager: Canadian Custom Packaging Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 10, 2024

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  • Active Ingredients

    Colloidal Oatmeal 2%

  • Purpose

    Skin protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritations and itching due to eczema rash and dermatitis.

  • Warnings

    For external use only.

    When using this product, avoid contact with eyes.

    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

    • Avoid contact with eyes

    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
  • KEEP OUT OF REACH OF CHILDREN

    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, especially after bathing.

  • Inactive Ingredients

    allantoin, aloe barbadensis leaf juice, avena sativa (oat) extract, avena sativa kernel oil, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, caprylyl–caprylate/caprate citric acid, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) extract, moringa oil/hydrogenated moringa oil esters, oryza sativa (rice) bran extract, phenoxyethanol, polyglyceryl-2-stearate, potassium sorbate, rosmarinus officinalis (rosemary) leaf extract, simmondsia chinensis (jojoba) seed oil, stearyl alcohol, tocopherol, trisodium ethylenediamine disuccinate, vitis vinifera (grape) seed oil, water/aqua, xanthan gum.

  • PRINCIPAL DISPLAY PANEL

    Skinfix_US_Soothing_Body_Cream_BOX_V4_R - BOX.jpg

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH BODY 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54291-038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    RICE BRAN (UNII: R60QEP13IC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ROSEMARY (UNII: IJ67X351P9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54291-038-01236 mL in 1 TUBE; Type 0: Not a Combination Product12/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/23/2015
    Labeler - Canadian Custom Packaging Company (207062514)
    Registrant - Canadian Custom Packaging Company (207062514)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging Company207062514manufacture(54291-038)
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