Otc - Active Ingredient
Active Ingredients
Menthol 4 %
Lidocaine 4 %
Venia Patch
FDA Label NDC 69512-700
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alivio Medical Products, Llc for the product Venia Patch (NDC 69512-700). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, otc - keep out of reach of children, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical anesthetic
Topical anesthetic
Indications & Usage
Uses:
For the temporary relief of minor aches and muscle pains associated with arthritis, simple
backache, strains, muscle soreness and stiffness
Warnings
Warnings:
-Only for external use. Use only as directed or by a health professional.
-Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth,
genitals, or any other mucous membranes.
-Do not cover with bandage.
-Keep out of reach of children.Consult physician for children under 12.
-Consult your physician: if pregnant or pain persists or worsens.
Dosage & Administration
Directions:
-Adults and children 12 years and over. Apply patch to affected area 1 to 2 times daily or
as directed.
-Instructions for use:
-Clear and dry the affected area
-Open pouch and remove one patch
-Remove any protective film and apply directly to affected area of pain
-Wash hands with soap and water after applying patch
-Reseal pouch containing unused patches after each use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Consult physician for children under 12
Inactive Ingredient
Other ingredients:
Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2 Ethylhexyl Acrylate, Glycerin, Isopropyl
Myristate, Methyl Acrylate, Nonoxynol 30, Polyacrylate, Polyacrylic Acid, Polysorbate 80, Sorbitan
Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Dioxide, Water
Package Label.Principal Display Panel
Copy Of Label (Venia New)
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