Otc - Active Ingredient
Zinc Oxide 20%
Zinc Oxide Ointment
FDA Label NDC 64772-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Derma Sciences Canada Inc. for the product Zinc Oxide (NDC 64772-201). 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 - when using, inactive ingredient, otc - do not use, otc - purpose, warnings, otc - keep out of reach of children, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - When Using
When using this product
- do not get into eyes
Inactive Ingredient
light mineral oil, petrolatum
Otc - Do Not Use
Do not use on
- deep puncture wounds
- animal bites
- serious burns
Otc - Purpose
Skin Protectant
Warnings
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
Do not use on
■ deep or puncture wounds ■ animal bites ■ serious burns
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.
Otc - Questions
Questions?
Call 800-840-9041 Monday through Friday 9:00 AM to 5:00 PM EST
Storage And Handling
Other Information
store between 15°C to 30°C (59°F to 86°F)
avoid excessive heat
Dosage & Administration
Directions
- apply as needed
Indications & Usage
Uses
dries the oozing and weeping of:
■ poison ivy ■ poison oak ■ poison sumac
Otc - Stop Use
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 - Ask Doctor
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
Package Label.Principal Display Panel
Zinc Oxide Ointment 16oz (Gen23400 Bottle Rev0)
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