Active Ingredient
Zinc Oxide
Procure Zinc Oxide Ointment
FDA Label NDC 55681-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Twin Med Llc for the product Procure Zinc Oxide (NDC 55681-017). 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
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and helps seal out wetness
- dries the ozzing and weeping of poison ivy, poison oak and posion sumac
Warnings
Warnings
For external use only.
When Using This Product
When using this product do not get into eyes
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
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
Directions:
For Diaper Rash:
- change wet and soiled diapers promptly
- cleanse the siaper area and allow to dry
- apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or when exposure to wet diapers may be prolonged
For poison ivy, oak and suman: apply as needed
Inactive Ingredients
Inactive ingredients: Ceteareth 20, Cetostearyl Alcohol, Light Mineral Oil, Petrolatum
* Please review the disclaimer below.
