Terocin Patch
FDA Label NDC 50488-1001

10 label sections · Submitted to the FDA by Alexso, Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alexso, Inc for the product Terocin (NDC 50488-1001). 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, uses:, warnings:, do not use: on irritated skin, on open wounds, cuts, damaged or infected skin., keep out of reach of children., directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Lidocaine 4%

Menthol 4%

Purpose

Topical Anesthetic 

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, bruises, and sprains.

Warnings:

  • For External Use Only. Use only as directed or as directed by a health professional.

Do Not Use: On Irritated Skin, On Open Wounds, Cuts, Damaged Or Infected Skin.

  • Avoid contact with eyes, mouth, genitals, or any other mucous membranes.
  • Do not cover with bandage or other dressings.

Keep Out Of Reach Of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions:

Adults and children 12 years and over: Apply patch to affected area 1 to 2 times daily or as directed.

Instructions for use:

  • Clean and dry the affected area.
  • Open pouch and remove one patch.
  • Remove any protective film and apply directly to affected area of pain.
  • Place the provided support backing over the applied patch and press gently to help secure the patch in place.
  • Wash hands with soap and water after applying patch.
  • Reseal pouch containing unused patches after each use.

    • Children under 12 years: Ask a physician.

Other Information:

Store in a dry, cool place
For Comments or Questions, call 888-495-6078

Inactive Ingredients:

Aloe Barbadensis Vera Leaf Juice, Diazolidinyl Urea, EDTA Disodium Salt, Glycerin, Iodopropynyl Butylcarbamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, Water 

Topical Pain Relief Patch

Alexso, Inc.

Package/Label Principal Display Panel

Terocin Patch
Lidocaine 4% / Menthol 4%

Topical Pain Patch
for long lasting relief

NDC 50488-1001-1

Qty: 10 Flexible Patches
(5 per Resealable Pouch) x 2

Manufactured for:
Alexso, Inc.
2317 Cotner Avenue
Los Angeles, CA 90064

Patent Pending

Package/label Principal Display Panelterocin Patchlidocaine 4% / Menthol 4%topical Pain Patchfor Long Lasting Reliefndc 50488-1001-1qty: 10 Flexible Patches (5 Per Resealable Pouch) X 2manufactured For: Alexso, Inc.2317 Cotner Avenuelos Angeles, Ca 90064patent Pending (Terocin Patch 01)

Package/label Principal Display Panelterocin Patchlidocaine 4% / Menthol 4%topical Pain Patchfor Long Lasting Reliefndc 50488-1001-1qty: 10 Flexible Patches (5 Per Resealable Pouch) X 2manufactured For: Alexso, Inc.2317 Cotner Avenuelos Angeles, Ca 90064patent Pending (Terocin Patch 01)

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