Active Ingredients
Menthol 0.15%
Zinc oxide 1.0%
The following Structured Product Label (SPL) was submitted to the FDA by Vi-jon for the product Medicated (NDC 0869-0551). 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, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Menthol 0.15%
Zinc oxide 1.0%
External analgesic
Skin protectant
Uses for the temporary relief of paina and itching due to:
dries the oozing and weeping of:
For external use only
avoid contact with the eyes
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
If swallowed, get medical help or contact a Poison Control Center right away
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 - do not use, consult a doctor
talc, acacia, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate
This product is sold by weight, not by volume. Some settling may occur during handling and shipping
Made in the USA with US and foreign components
Vi-Jon
One Swan Drive
Smyrna, TN 37167
* Please review the disclaimer below.