Active Ingredients
Benzocaine 20.0% w/w
Eclipse Topical Analgesic
FDA Label NDC 54723-668
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sambria Pharmaceuticals, Inc. for the product Eclipse Topical Analgesic (NDC 54723-668). 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, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, 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 temporary relief of pain and itching due to minor skin irritation.
Warnings
For external use only
Avoid contact with eyes
Otc - Stop Use
Stop use and ask doctor if
• Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again within a few days. Discontinue use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
• If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
For adults and children two-years or older: Apply to affected area not more then 3 or 4 times daily. Children under 2 years of age: consult a physician.
Inactive Ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetearetj-25, Chondroitin Sulfate, Diethylhexyl Sodium Sulfosuccinate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Isopropyl Palmitate, Laureth-7, Melaleuca alternifolia (Tea Tree) Leaf Oil, Methylfulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Safflower Oil, Stearic Acid, Triethanolamine
Other Information
Protect this product from excessive heat or direct sun.
Questions Or Comments?
FDA Registered: NDC No. 54723-668-03
800-759-6876
Package Label.Principal Display Panel
Packet (Packet)
* Please review the disclaimer below.
