LIDOTHOL- lidocaine, menthol patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

Terrain Pharmaceuticals

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidothol is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to muscle or ligament strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact. Other uses may be considered if deemed clinically relevant. Lidothol 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.

Product summary:

Lidothol is supplied in the following dosage form: 15 Patches: 3 per re-­‐sealable pouch, 5 pouches NDC 53225­‐1025­‐1 Manufactured For: Terrain Pharmaceuticals 50 West Liberty Street, Suite 1080 Reno, NV 89501 877.985.4377

Authorization status:

unapproved drug other

Summary of Product characteristics

LIDOTHOL- LIDOCAINE, MENTHOL PATCH
TERRAIN PHARMACEUTICALS
_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._
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LIDOTHOL PATCH
LIDOTHOL (LIDOCAINE 4.5% / MENTHOL 5% PATCH)
For Topical Use Only
Do not use:
On the face or rashes
On wounds, damaged, or infected skin
In the eyes, mouth or other mucous membranes
On genitals
With a heating pad
Ask a doctor before use if:
You are allergic to topical products or any ingredients in this
product
You are pregnant or breast feeding
You are under age 18
When using this product:
Wash hands after applying or removing patch
Avoid contact with eyes
If eye contact occurs, rinse thoroughly with water
Stop use and consult your physician if:
Rash, irritation, or itching develops
Condition worsens Keep out of reach of children
LIDOTHOL PATIENT INFORMATION.
Before you begin using this medication: read this entire patient
information sheet. If you
have any questions, please consult your physician or pharmacist.
Inform your physician
if your condition does not improve or if it worsens.
This information may not include all of the details needed to use
Lidothol safely and
effectively. Discuss use with your doctor or pharmacist.
WHAT IS LIDOTHOL?
A topical pain relief patch consisting of the local anesthetic
Lidocaine (4.5%) and the
topical analgesic Menthol (5%).
WHAT IS LIDOTHOL USED FOR?
The patch assists patients in the management of mild to moderate acute
pain or mild to
moderate aches. Lidothol is applied to the skin at the specific region
experiencing these
pain symptoms. The synthesis of Lidocaine and Menthol is a highly
effective combination
of pain relievers working to alleviate discomfort while the root cause
is being managed
and treated by your healthcare providers.
DO NOT USE:
If you are allergic to any of the ingredients in this product
On wounds or damaged skin
With a heating pad
If you are pregnant, planning to become pregnant, or