Active Ingredient
Zinc Oxide 25%
Skin Protectant Ointment
FDA Label NDC 70000-0488
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Skin Protectant (NDC 70000-0488). 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, otc - 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
- 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
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
Otc - 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
Inactive Ingredients
Cetostearyl Alcohol, Light Mineral Oil, Macrogol Cetostearyl Ether 12, White Soft Paraffin
Questions And Comments?
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