Otc - Active Ingredient
Zinc Oxide
Careall Zinc Oxide Ointment
FDA Label NDC 51824-032
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New World Imports Inc for the product Careall Zinc Oxide (NDC 51824-032). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
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.
Indications & Usage
Helps treat and prevent diaper rash
Protects chafed skin due to diaper rash and helps seal out wetness
Warnings
For external use only.
When using this product do not get into eyes
Stop use and ask a doctor if
Condition worsens
Symptoms last more than 7 days or clear up and occur again with a few days
Dosage & Administration
Change wet and soiled diapers promptly
Cleanse the diaper area
Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Inactive Ingredient
Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin
* Please review the disclaimer below.
