Label: ECZEMA FAST HEALING BODY WASH- colloidal oatmeal lotion/shampoo

  • NDC Code(s): 10738-205-63
  • Packager: Genuine Virgin Aloe Corporation
  • 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 January 31, 2023

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  • Active Ingredient

    Colloidal Oatmeal 1.5%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to: •eczema •rashes •poison ivy •insect bites

  • Warnings

    For external use only

    When using this product • patch test before use • Keep out of eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if • condition worsens • symptoms last for more than 7 days, or clear and occur again in a few days

    Do not use • on deep puncture wounds • on animals • on bites • on serious burns

    Keep out of reach of children. If swallowed get medical help and contact a Poison Control Center right away.

  • Directions

    Dispense a dime to quarter-sized amount into palm, gently massage onto wet skin. Rinse. For extra cleansing, allow to sit for 30 seconds and then rinse.

  • Ingredients

    water, sodium C14-16 olefin sulfonate, cocamidopropyl hydroxysultaine, cocamide MIPA, hydroxypropyl bis-hydroxyethyldimonium chloride, aloe barbadensis leaf juice, cannabis sativa seed oil, citric acid, glycerin, hedera helix (ivy) leaf extract, arnica montana flower extract, sambucus nigra flower extract, malva sylvestris (mallow) flower extract, tilia platyphyllos flower extract, cucumis sativus (cucumber) fruit, parietaria officinalis extract, triticum vulgare (wheat) germ oil, allantoin, bisabolol, tocopheryl acetate (vitamin E), sodium benzoate, potassium sorbate.

  • Questions?

    1-800-279-7282 M-F 8am-4pm PST

  • PRINCIPAL DISPLAY PANEL

    Triderma MD

    Eczema Fast Healing TM Body Wash

    For Sensitive Skin

    Helps relieve minor skin irritation & itching due to eczema & rashes

    Colloidal Oatmeal

    16 Fl OZ (473 mL)

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    ECZEMA FAST HEALING BODY WASH 
    colloidal oatmeal lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE (UNII: 1EO3O1X7HG)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)  
    TILIA PLATYPHYLLOS FLOWER (UNII: 1R02M833TN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    PARIETARIA OFFICINALIS LEAF (UNII: W2I83529KR)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10738-205-63473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2019
    Labeler - Genuine Virgin Aloe Corporation (961374147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genuine Virgin Aloe Corporation961374147manufacture(10738-205)
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