Vonaflex Effective Pain Relief Topical Analgesic Cream
FDA Label NDC 87359-987

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Optimal Laboratories, Llc for the product Vonaflex Effective Pain Relief Topical Analgesic (NDC 87359-987). 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 drug facts, active ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Lidocaine hydrochloride 4%

Purpose

Topical Analgesic

Uses:

  • For temporary relief of pain

Warnings:

For external use only

Do Not Use

  • in large quantities, particularly over raw surfaces or blistered areas

When Using This Product

  • Avoid contact with the eyes

Stop Use And Ask A Doctor If

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions:

  • Adults and children 2 years of age and older: Apply a thin layer to the affected area and massage until the lotion is no longer visible,  up to three times a day.
  • Children under 2 years of age: consult a doctor.

Other Information:

  • Store at 20-25°C (68-77°F) and protect from moisture

Inactive Ingredients:

Arnica Montana Extract, Caramel, Carbomer, Cetearyl Alcohol, Cetyl Esters, Disodium EDTA, Ethoxydiglycol, Ethyl Macadamiate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Flower Oil, Menthyl Lactate, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Scutellaria Baicalensis Root Extract, Tetrahydrodiferuloylmethane, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

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