Active Ingredient
Zinc Oxide 20%
Zinc Oxide 20% Ointment
FDA Label NDC 68016-159
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Zinc Oxide 20% (NDC 68016-159). 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, keep out of the reach of children, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
- Helps treat and prevent diaper rash
- Protects chafed skin due to diaper rash - helps protect skin from wetness
- Protects and dries the oozing and weeping of poison ivy, poison oak and poison sumac
- Helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Warnings
For External Use Only
- When using this product avoid contact with eyes
- Stop use and ask a doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.
Directions
- Change wet and soiled diapers promptly
- Cleanse the diaper area and allow to dry
- Apply ointment liberally as often as necessary. With each diaper change, especially at betime or anytime when exposure to wet diapers may be prolonged
Other Information
- Store at controlled room temperature 20° - 25°C (68° - 77°F)
Inactive Ingredients
Mineral Oil, Petrolatum
Distributed By:
Pharmacy Value Alliance, LLC.
407 East Lancaster Avenue, Wayne, PA. 19087
www.emersongroup.com
Product of PRC
* Please review the disclaimer below.
