Otc - Active Ingredient
Active Ingredient Purpose
Zinc Oxide (1.8% w/w) Skin Protectant
Zinc Oxide
FDA Label NDC 68786-226
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sion Biotext Medical Ltd for the product Zinc Oxide (NDC 68786-226). 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, uses:, warnings:, when using this product:, stop use and ask a doctor if:, keep out of reach of children., directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
- Helps treat and prevent diaper rash
- Temporarily protects
- minor cuts
- scrapes and
- burns
- dries the oozing and weeping of
- poison ivy
- poison oak
- poison sumac
Warnings:
For External Use Only.
When Using This Product:
Do not get in eyes.
Stop Use And Ask A Doctor If:
- condition worsens
- symptoms last more than 7 days or clear up and occur again in a few days, consult a physician
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
For skin protectant:
- Apply liberally as needed For diaper Rash:
- change wet and soiled diapers promptly
- allow to dry
- apply ointment liberally with each diaper change
Other Information:
- Store at room temperature
- avoid excessive heat
- contains color additives including FDC yellow # 5
Principal Display Panel
Zinc Oxide Ointment (Sion Zinc Oxide)
* Please review the disclaimer below.
