TRUBREXA- lidocaine and capsaicin patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

Strand Health Group

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Trubrexa TM Transdermal Patch is indicated in adults over the age of 12 years old for the treatment of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more. Trubrexa TM Transdermal Patch is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. 7.1 Pregnancy Trubrexa TM Transdermal Patch has not been studied in pregnancy. Maternal use is not expected to result in fetal exposure. Animal studies have shown no adverse effects when lidocaine and capsaicin are administered and absorbed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Trubrexa TM Transdermal Patch should only be used during pregnancy if clearly needed or advised by a healthcare professional. All pregnancies have a background risk of birth d

Product summary:

12.1 How Supplied Trubrexa TM Transdermal Patch comes in a sealed pouch bag. Each patch is 2 in x 2 in (5.08 cm x 5.08 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Trubrexa TM Transdermal Patch logo. Trubrexa TM Transdermal Patch is available as a unit box containing 32 patches (8 pouch bags). NDC 83295-4000-1 12.2 Storage Store unit box between 68 o -77 o F (20 o -25 o C). Excursions between 15 o -30 o C (59 o -86 o F) are allowed. Keep Trubrexa TM Transdermal Patch in the sealed pouch bags until immediately before use. 12.3 Handling and Disposal Unintended exposure to capsaicin can cause severe irritation of eyes, skin, respiratory tract, and mucous membranes. Avoid contact with your eyes, nose, or mouth. Keep used and unused patches out of the reach of children and pets. Pouch bags are not child resistant. Wash hands with soap and water after handling the patch. If irritation or a burning sensation occurs during application, remove the patch and do not reapply until the irritation subsides. After use, fold patches so that the adhesive side sticks to itself, then safely discard used patches where children and pets cannot get to them.

Authorization status:

unapproved drug other

Summary of Product characteristics

TRUBREXA- LIDOCAINE AND CAPSAICIN PATCH
STRAND HEALTH GROUP
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
TRUBREXA TRANSDERMAL PATCH
TRUBREXA TRANSDERMAL PATCH
EXTENDED TIME RELEASE
LIDOCAINE 4.75%
CAPSAICIN 0.025%
RX ONLY
1. INDICATIONS & USAGE
Trubrexa
Transdermal Patch is indicated in adults over the age of 12 years old
for the
treatment of acute and chronic pain in muscles and joints associated
with muscle
soreness, strains, sprains, arthritis, simple backache, muscle
stiffness, and more.
2. DOSAGE & ADMINISTRATION
_2.1 Important Dosage and Administration Instructions_
Unintended exposure to capsaicin can cause severe irritation of the
eyes, mucous
membranes, respiratory tract, and skin in healthcare providers and
others.
Because unintended exposure to capsaicin can cause severe irritation
of eyes,
mucous membranes, respiratory tract, and skin, when administering
Trubrexa
Transdermal Patch it is important to follow these procedures:
Keep Trubrexa
Transdermal Patch in the sealed pouch until immediately before
use.
Use Trubrexa
Transdermal Patch only on dry, intact (unbroken) skin.
During administration, avoid unnecessary contact with any items in the
room,
including items that the patient may later have contact with, such as
horizontal
surfaces and bedsheets.
Immediately after use, clean all areas of skin that had contact with
Trubrexa
Transdermal Patch.
Ensure all used and unused pieces Trubrexa
Transdermal Patch are properly
disposed of.
_2.2 Dosing and Instructions for Use_
Tear open pouch bag and remove one patch. Place remaining patches back
in pouch
bag and seal the pouch bag closed.
Peel the clear plastic film away and apply Trubrexa
Transdermal Patch to intact
skin to cover the most painful area. Apply one patch per day for up to
12 hours
within a 24 hour period (12 on, 12 off). One single Trubrexa
Transdermal Patch
TM
TM
TM
TM
TM
TM
TM
TM
TM
may be us