Label: TRAUMACARE - arnica montana capsule 

  • Label RSS
  • NDC Code(s): 63545-517-01
  • Packager: Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/12

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

  • Active Ingredients

    Active Ingredients:

    TraumaCare 01 500mg Arnica Montana 1M, TraumaCare 02 500mg Arnica Montana 12C

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  • Purpose

    Speeds recovery from Accidents, Sports Injuries, and Surgery

    • fractures and sprains
    • muscle pulls
    • facial injuries

    Reduces pain, bruising, and swelling after major trauma

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  • Keep Out of Reach of Children

    Keep this and all medication out of the reach of children.

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  • Uses

    Reduces pain, bruising, and swelling after major trauma.

    TraumaCare is a single complete dosage regimen of Homeopathic Arnica used to speed healing of soft tissue damaged by a major trauma such as an accident, surgery or sports injury. Clinical research has shown patients taking the TraumaCare regimen recover (their bruises and swelling go away) in as little as half the time of patients taking a placebo.

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  • Warnings

    Warnings:

    If you are pregnant or nursing, consult a health professional before use. For children under 6 years old, see a doctor.

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  • Drug Interactions

    Drug Interactions: Do not take together with Talwin tm or Talwin NX tm

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  • Directions

    Directions

    Adults and children 6 years and older. Take one capsule every 8 hours starting as soon as possible after accident, injury, or surgery. For a planned surgery, take one capsule 1-12 hours prior to surgery, then every 8 hours. Do not eat or drink anything for 15 minutes minutes before and after taking TraumaCare. If symptoms persist see your doctor.

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  • Additional Information About Product

    What is Arnica?

    Homeopathic Arnica Montana - also known simply as "Arnica" - has been used for centuries to reduce the uncomfortable swelling and bruising associated with a physical trauma. Prepared from a daisy-like plant native to the Swiss Alps, the herb is toxic; conversely, the resulting homeopathic medication is not, due to the small doses of Arnica used in Homeopathy.

    What is TraumaCare?

    TraumaCare is a controlled dosage regimen combining prescription-strength and low-potency Homeopathic Arnica Montana. Clinically proven, TraumaCare goes beyond treating pain - it speeds healing. Recommended by doctors, TraumaCare has demonstrated a reduction in the amount of visible bruising in patients within the first day and even more dramatically one week later.

    What is a Major Trauma?

    Major physical traumas result in broken or crushed blood vessels bleeding into injured muscle and/or connective tissue. TraumaCare is proven in research studies to speed the body's natural response to injury. The body's healing process is to re-establish normal blood flow, re-build the injured tissue, and remove the damaged, torn, crushed, or cut muscle fibers and connective tissue.

    When is TraumaCare effective?

    Specifically designed to speed recovery from a major physical trauma, Traumacare is generally considered too strong for a minor bump or bruise. A "major trauma" is an injury which causes disruption to your normal routine, taking several days or weeks to heal on its own.

    Trust your recovery to the Arnica Experts!

    TraumaCare TM

    TraumaCare3

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  • Inactive Ingredients

    Inactive Ingredients : Sucrose 400mg, Lactose 100 mg, Capsules contain Hypromellose, Red Iron Oxide, Titanium Dioxide

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  • Package Label

    TraumaCare TM Reduces pain, bruising, and major swelling after major trauma

    Prescription Strength Homeopathic Arnica

    Speeds recovery from Accidents, Sports Injuries, and Surgery

    Speeds recovery from major traumas:

    • fractures and sprains
    • muscle pulls
    • facial injuries
    • knee injuries
    • shoulder injuries
    • orthopedic surgery
    • oral surgery
    • back surgery
    • plastic surgery
    • general surgery
    Accidents:

    • Car accidents
    • bike accidents
    Plus sports injuries:

    • Basketball
    • Baseball
    • Football
    • Hockey
    • Tennis
    • Soccer

    THIS PRODUCT IS SAFETY SEALED. THE BOX IS SEALED AND THE CAPSULES ARE INDIVIDUALLY BLISTER SEALED.DO NOT USE IF SEALS OR BLISTERS ARE BROKEN.

    Printed with soy based inks by a Forest Stewardship Council Certified Printer.

    Developed and distributed by Alpine Pharmaceuticals, San Rafael, CA 94901 a wholly owned subsidiary of Hahnemann Laboratories, Inc. All rights reserved.
    Lot:TCQ221   Use before Feb 2012  NDC 63545-517-01
    A Product of Alpine Pharmaceuticals

    Questions or Comments call 888-746-4542 email info@alpinepharma.com or visit online at www.alpinepharma.com

    ALL NATURAL 12 capsules  For Adults and Children 6 years and older

    TraumaCare1 label

    TraumaCare2 label

    TraumaCare4 label


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  • INGREDIENTS AND APPEARANCE
    TRAUMACARE 
    arnica montana capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63545-517
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 1 [hp_M]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE  
    LACTOSE  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color orange (orange/peach) Score no score
    Shape CAPSULE (capsule) Size 18mm
    Flavor Imprint Code TraumaCare01
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63545-517-01 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 06/30/2007
    Labeler - Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals (147098081)
    Registrant - Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals (147098081)
    Establishment
    Name Address ID/FEI Business Operations
    Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals 147098081 manufacture(63545-517)
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