FDA Label for Zinc Oxide
View Indications, Usage & Precautions
Zinc Oxide Product Label
The following document was submitted to the FDA by the labeler of this product Sion Biotext Medical Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient Purpose
Zinc Oxide (1.8% w/w) Skin Protectant
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
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