Traumacare
FDA Label NDC 63545-517

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hahnemann Laboratories, Inc. Dba Alpine Pharmaceuticals for the product Traumacare (NDC 63545-517). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, keep out of reach of children, uses, warnings, drug interactions, directions, additional information about product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Keep Out Of Reach Of Children

→ Uses

→ Warnings

→ Drug Interactions

→ Directions

→ Additional Information About Product

→ Inactive Ingredients

→ Package Label

Active Ingredients

Active Ingredients:

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

Purpose

Speeds recovery from Accidents, Sports Injuries, and Surgery

fractures and sprains
muscle pulls
facial injuries

Reduces pain, bruising, and swelling after major trauma

Keep Out Of Reach Of Children

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

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.

Warnings

Warnings:

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

Drug Interactions

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

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.

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