Active Ingredient(S)
Zinc Oxide 20%
Nivagen Zinc Oxide Ointment
FDA Label NDC 75834-170
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nivagen Pharmaceuticals, Inc. for the product Nivagen Zinc Oxide (NDC 75834-170). 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(s), use(s), indications & usage, warnings, otc - keep out of reach of children, 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
Use(S)
Skin Protectant
Indications & Usage
USES
■ Helps treat and prevent diaper rash
■ Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac
Warnings
For External Use Only
When using this product ■ do not get into eyes
Stop use and ask a doctor if
■ conditionworsens
■ symptoms last more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ For diaper rash: 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 bedtime or anytime when exposure to wet diapers may be prolonged.
■ For poison ivy, oak, and sumac: Apply as needed.
Other Information
■ Store at room temperature
■ Avoid excessiveheat
Inactive Ingredients
Cetomacrogol 1000, Cetostearyl Alcohol, Light Liquid Paraffin, White Soft Paraffin
* Please review the disclaimer below.
