Label: TRIDERMA ECZEMA FAST HEALING FACE AND BODY- colloidal oatmeal cream

  • NDC Code(s): 10738-054-20, 10738-054-25, 10738-054-40, 10738-054-45, view more
    10738-054-50, 10738-054-55, 10738-054-65
  • Packager: Genuine Virgin Aloe Corporation
  • Category: HUMAN OTC DRUG LABEL

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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  • Drug Facts

  • Active ingredient

    Colloidal oatmeal 1.5%

  • Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses temporarily protects and helps relieve minor skin irritation and itching due to: •eczema •rashes

  • WARNINGS

    Warnings For external use only.

    Do not use •on deep puncture wounds •on infections •on lacerations

    When using this product •do not get into eyes

    Stop use and ask a doctor if •condition worsens or does not improve within 7 days

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

  • DOSAGE & ADMINISTRATION

    Directions •apply twice a day or as needed.

  • STORAGE AND HANDLING

    Other Information •store at room temperature.

  • INACTIVE INGREDIENT

    Inactive ingredients: water, cetearyl alcohol, urea, isopropyl palmitate, arnica montana flower extract, glycerin, polysorbate 60, cera alba (beeswax), dimethicone, allantoin, zinc PCA, sodium PCA, aloe barbadensis leaf juice*, panthenol (pro-vitamin B5), butyrospermum parkii (shea) butter, tocopheryl acetate (vitamin E), sodium hyaluronate, cetyl alcohol, sodium phytate, sodium hydroxide, phenoxyethanol, ethylhexylglycerin.
    *Certified Organic Ingredient - Mayacert Certifier

  • QUESTIONS

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

  • SPL UNCLASSIFIED SECTION

    Temporarily protects & helps relieve minor skin irritation due to eczema & rashes

    Helps relieve itching

    AP4 BOTANICAL

    ALOE VERA COMPLEX

    with Colloidal Oatmeal

    Maximum Strength

    Healing Botanicals

    Eczema Fast Healing™ cream helps promote fast relief for itching and rashes due to Eczema related symptoms.

    This rich cream contains essential healing botanicals, vitamins and AP4 ® Aloe Vera Complex. It provides long lasting moisture and helps

    relieve itching without harmful drugs.

    Non-Greasy

    No Added Fragrance or Parabens

    Dist. by: Genuine Virgin Aloe Corp.,

    Corona, CA 92879

    •AP4® Aloe Vera Complex, a proprietary botanical blend



    • Colloidal Oatmeal, helps relieve skin irritations due to Eczema and rashes



    • Shea Butter, Arnica Montana Flower & Beeswax



    • Vitamins B and E

    DERMATOLOGIST TESTED

    Rooted from a medical heritage, TriDerma MD ® was founded after one woman’s struggle to find safe and effective skin healing.

    At TriDerma MD ®, we strive to create the perfect healing formulations for specific skin irritations. Our products are made using only

    the finest quality, most effective ingredients. We are passionate in our pursuit of fast healing, natural botanicals that do not cause

    harmful side effects.

    Quality you can feel,

    results you can see.     ®

  • Packaging

    4.2 oz carton4.2 oz tube

    Eczema Fast Healing Cream_6 oz_Tube_12.15.2020_PRINT

  • INGREDIENTS AND APPEARANCE
    TRIDERMA ECZEMA FAST HEALING FACE AND BODY 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    UREA (UNII: 8W8T17847W)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10738-054-501 in 1 CARTON10/01/2019
    1NDC:10738-054-5514 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10738-054-201 in 1 CARTON10/01/2019
    2NDC:10738-054-2562 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:10738-054-401 in 1 CARTON10/01/2019
    3NDC:10738-054-45119 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:10738-054-65170 g in 1 TUBE; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2019
    Labeler - Genuine Virgin Aloe Corporation (961374147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genuine Virgin Aloe Corporation961374147manufacture(10738-054)
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