Active Ingredient
Zinc Oxide 20% w/w
Zinc Oxide Ointment
FDA Label NDC 68001-533
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bluepoint Laboratories for the product Zinc Oxide (NDC 68001-533). 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
• 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 right away.
Directions
For poison ivy, oak, and sumac: apply as needed.
Other Information
- Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
- Store at room temperature.
- Preserve in well-closed container.
- See crimp of tube or carton for Lot number and Expiry Date.
Inactive Ingredients
Cetostearyl Alcohol, Light Mineral Oil, Macrogol Cetostearyl Ether 20, White Petrolatum.
Questions?
Contact 1-800-707-4621
Gopaldas Visram & Company Limited.
Plot No. A327, T.T.C. Indl. Area, M.I.D.C.
Mahape, Navi Mumbai- 400710.
For BluePoint Laboratories
* Please review the disclaimer below.
