Active Ingredients
Camphor 6.55%
Menthol 6.55%
Zepol Topical Analgesic Ointment
FDA Label NDC 55715-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Zepol S.a. for the product Zepol Topical Analgesic (NDC 55715-001). 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 ingredients, purpose, uses, warnings, otc - ask doctor, keep out of reach of children., directions:, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, strains, bruises and sprains.
Warnings
For external use only.
Avoid contact with eyes.
Warnings (Continued)
Do not apply to wounds or damaged
skin.
Do not bandage tightly.
Otc - Ask Doctor
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact Poison Control Center right away.
Directions:
-Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. -Children under 2 years of age: Consult a physician.
Other Information
Store at 30 degrees C (86 degrees F).
Inactive Ingredients
Eucalyptol, Petrolatum, Thyme Oil, Turpentine Oil Rectified.
Package Label.Principal Display Panel
Zepol Topical Analgesic 1 Oz (Zepol Topical Analgesic 1oz)
Zepol Topical Analgesic Outer Box (Zepol Topical Analgesic)
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