Label: TRIDERMA BRUISE DEFENSE HEALING -DIABETICS- arnica montana flower extract cream

  • NDC Code(s): 10738-065-20, 10738-065-25, 10738-065-40, 10738-065-45, view more
    10738-065-50, 10738-065-55
  • 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

    Arnica Montana Flower Extract 1X 1.60% HPUS

  • Purpose

    Muscle Pain, Trauma, Pain & Stiffness. Swelling from injuries, discoloration from bruises.

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

  • INDICATIONS & USAGE

    Uses Temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls Reduces pain, swelling and discoloration from bruises

  • WARNINGS

    Warnings For external use only. 

    Avoid contact with eyes, mucous membranes, damaged skin and wounds.

    Do not use if you are allergic to Arnica Montana or to any of this product’s inactive ingredients.

    When using this product use only as directed. Do not bandage tightly or use a heating pad. Stop use and ask a doctor if condition persists for more than 7 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 Apply a thin layer of cream to affected area and massage gently as soon as possible after minor injury. Repeat 3X a day or as needed.

  • STORAGE AND HANDLING

    Other Information Do not use if glued carton end flaps are open or if the tube seal is broken. Non-greasy, store at 20-25°C.

  • INACTIVE INGREDIENT

    Inactive ingredients: water, dimethyl sulfone, isopropyl palmitate, caprylic/capric triglyceride, glycerin, cetearyl alcohol, cera alba (beeswax), polysorbate 60, tocopheryl acetate (vitamin E), C12-15 alkyl benzoate, aloe barbadensis leaf juice†, allantoin, behentrimonium chloride, cyclopentasiloxane, cyclohexasiloxane, hydroxyethylcellulose, sodium hydroxide, phenoxyethanol, ethylhexylglycerin.†Certified Organic Ingredient - Mayacert Certifier 

  • QUESTIONS

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

  • SPL UNCLASSIFIED SECTION

    Temporarily relieves muscle pain & stiffness due to minor injury

    Reduces pain, swelling & discoloration

    AP4 ® BOTANICAL

    ALOE VERA COMPLEX

    with Arnica Montana

    Homeopathic Medicine

    For Skin that Bruises Easily or Heals Slowly

    Bruise Defense™ Healing Cream helps promote the appearance of healthy skin and faster healing from bruising due to certain types of medication, surgical procedures or simple skin trauma.

    Maximum Strength Healing Botanicals

    This concentrated cream contains AP4 ® Botanical Aloe Complex, Arnica and MSM to help provide soothing relief for damaged skin.

    CERTIFIED ORGANIC ALOE

    cruelty free

    LEARN MORE @  triderma

    www.triderma.com

    MADE IN THE USA

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

    Dermatologist Tested

    Helps Relieve:

    • Muscle pain and stiffness

    • Swelling from minor injury

    • Reduces discoloration from bruises

    Non-Greasy • No Cortisone Or Parabens

    No Added Fragrance

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

    - X is homeopathic dilutions.

    For people living with Diabetes, special care is needed to protect and heal the skin. Our line of specialized Diabetic products, Foot Defense™, Dry Skin Defense™ and Ulcer Defense™ helps provide a solution for these special skin problems.

    Quality you can feel, results you can see. ®

    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.

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  • INGREDIENTS AND APPEARANCE
    TRIDERMA BRUISE DEFENSE HEALING -DIABETICS 
    arnica montana flower extract cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER1.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    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:10738-065-501 in 1 CARTON08/30/2019
    1NDC:10738-065-5514 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10738-065-201 in 1 CARTON08/30/2019
    2NDC:10738-065-2562 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:10738-065-401 in 1 CARTON08/30/2019
    3NDC:10738-065-45119 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(10738-065)