Active Ingredient
Lidocaine HCL 5.0% w/w
Zovacil 5
FDA Label NDC 82067-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eurotas Pharmaceuticals, Llc for the product Zovacil 5 (NDC 82067-001). 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 ingredient, purpose, uses, warnings, directions, inactive ingredients, other information, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Uses
For the temporary relief of pain, soreness or burning. For temporary relief of anorectal discomfort associated with anorectal disorders or inflammation.
Warnings
For external use only
Avoid contact with eyes
Do not exceed the recommended daily dosage unless director by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using a finger or any medical device or applicator.
Stop use and ask doctor if
• Condition worsens, or does not improve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use.
Keep out of reach of children
• If a product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
For adults, when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product.
Apply externally to the affected area not more than 6 times daily. Children under 12 years of age: consult a physician.
Inactive Ingredients
Aqua (Deionized Water), Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Isoprpoyl Palmitate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine
Other Information
Protect this product from excessive heat and direct sun.
Questions Or Comments?
FDA Registered: NDC No 82067-100-60
Toll -Free 1-844-EUROTAS
Product Label
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