Label: TRIDERMA ULCER DEFENSE HEALING- calendula officinalis cream

  • NDC Code(s): 10738-057-20, 10738-057-25, 10738-057-40, 10738-057-45, view more
    10738-057-50, 10738-057-55
  • Packager: Genuine Virgin Aloe Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 2, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts 

  • Active ingredient

    Calendula Officinalis 1X HPUS 1.5%

  • Purpose 

    Speed healing, Minimizes recurrence, healing agent.

    HPUS indicates that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.

  • INDICATIONS & USAGE

    Uses •speed healing of wounds, sores, acne and lip sores  helps promote healing of cuts, scrapes, chafing, minor burns and sunburn

  • WARNINGS

    Warnings For external use only.

    Avoid contact with eyes. Intended for adults only. Do not use if you are allergic to Calendula Officinalis or to this product's inactive ingredients.

    Stop use and ask a doctor before use in case of deep puncture wounds, animal bites or serious burns and if condition persists for more than 4 days or worsens. 

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

  • DOSAGE & ADMINISTRATION

    Directions •read all package directions and warnings before use. When using this product use only as directed. Apply a thin layer to affected area and massage gently as soon as possible after minor injury. Apply 3X a day or as needed. •Sensitivity Test for a New User. Apply sparingly to one or two small affected areas during the first 7 days.  •if no discomfort occurs, follow the direction stated above.

  • STORAGE AND HANDLING

    Other information do not use if glued carton end flaps are open or if the tube seal is broken.   store at room temperature.

  • INACTIVE INGREDIENT

    Inactive ingredients: water, cetearyl alcohol, isopropyl palmitate, polysorbate 60, cera alba (beeswax), dimethicone, allantoin, zinc PCA, avena sativa (oat) kernel flour, aloe barbadensis leaf juice , butyrospermum parkii (shea) butter, tocopheryl acetate (vitamin E), panthenol (pro-vitamin B5), cetyl alcohol, sodium PCA, 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

    Speed healing of wounds & sores

    Helps promote healing of cuts, scrapes & chafing 

    DIABETICS

    AP4 ® Botanical

    ALOE VERA COMPLEX

    Calendula

    Homeopathic Medicine

    Maximum Strength

    Healing Botanicals

    Ulcer Defense™ Healing Cream is the perfect multi-purpose skin healer to help keep skin healthy and protected.


    It provides soothing relief and helps speed healing for minor to severe, hard-to-heal™ skin irritations.


    Formulated with our AP4 ® Organic Aloe* Complex, vitamins, minerals and essential healing botanicals, this powerful cream delivers fast results without harmful side effects.

    www.triderma.com 

    MADE IN THE USA 

    Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879 

    Dermatologist Tested

    Speeds Healing For:

    • Minor Burns & Sunburn

    Non-Greasy • No Cortisone Or Parabens

    No Added Fragrance

    - Uses have not been evaluated by Food and Drug Administration.

    - X is homeopathic dilutions.

    EXPERTS IN SKIN HEALING SINCE 1992

    TriDerma MD ® provides healing solutions for irritated skin without harmful side effects.


    It all began after one woman struggled to find safe and effective healing for her own skin problem.


    This journey led to the creation of our proprietary AP4 ® Organic Aloe* Complex which is key to all our products.

    QUALITY YOU CAN FEEL, RESULTS YOU CAN SEE. ®

    Each product is made using this powerful complex plus nature’s best botanicals and clinically proven ingredients.


    We are passionate in our pursuit to create fast healing products that work.

  • Packaging

    image

  • Packaging

    box

  • Packaging

    three

  • Packaging

    four

  • Packaging

    defense

  • Packaging

    seven

  • INGREDIENTS AND APPEARANCE
    TRIDERMA ULCER DEFENSE HEALING 
    calendula officinalis cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    OATMEAL (UNII: 8PI54V663Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    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:10738-057-501 in 1 CARTON08/30/2019
    1NDC:10738-057-5514 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10738-057-401 in 1 CARTON08/30/2019
    2NDC:10738-057-45119 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:10738-057-201 in 1 CARTON08/30/2019
    3NDC:10738-057-2562 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/30/2019
    Labeler - Genuine Virgin Aloe Corporation (961374147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genuine Virgin Aloe Corporation961374147manufacture(10738-057)