FDA Label for Zovacil 5

View Indications, Usage & Precautions

Zovacil 5 Product Label

The following document was submitted to the FDA by the labeler of this product Eurotas Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Lidocaine HCL 5.0% w/w


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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