Active Ingredient
Zinc Oxide 20% w/w
Rugby Zinc Oxide 20% Ointment
FDA Label NDC 0536-1316
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Rugby Zinc Oxide 20% (NDC 0536-1316). 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 ingredient, 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.
Label Section Quick Index
Purpose
Skin Protectant
Uses
• Dries the oozing and weeping of poison: • Ivy • Oak • Sumac
Warnings
For External Use Only
When Using This Product
• Do not get into eyes
• Do not use over large areas of the body
Stop Use And Ask A Doctor If
• The condition worsens
• Symptoms last more than 7 days or clear up and occur again within a few days
• If you are allergic to any of these ingredients
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
For poison ivy, oak, and sumac: apply as needed.
Other Information
• Store at room temperature between 15°-30°C (59°-86°F)
• Avoid excessive heat
Inactive Ingredients
Cetomacrogol 1000, Cetostearyl Alcohol, Light Mineral Oil, White Soft Paraffin (Petrolatum)
Questions And Comments?
1-800-645-2158
Label
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