Active Ingredient
Zinc Oxide 20%
Zinc Oxide 20% Ointment
FDA Label NDC 69396-086
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa for the product Zinc Oxide 20% (NDC 69396-086). 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, keep out of the reach of children, warnings, stop use and ask doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
- Protects skin
- Protects and releives chafed skin due to diaper rash - helps seal out wetness
- Dries the oozing and weeping of poison ivy, oak and sumac
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Warnings
For External Use Only
- When using this product avoid contact with eyes
Stop Use And Ask Doctor If
Stop use and ask doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.
Directions
- Apply ointment liberally as often as necessary
- For the treatment of diaper rash, change wet and soiled diapers promptly
- Cleanse the diaper area and allow to dry
- Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged
Other Information
- Store at controlled room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredients
Cetomacrogol 1000, Cetostearyl alcohol, Light Mineral Oil, White Petrolatum
Distributed By:
Trifecta Pharmaceuticals USA, LLC.®
101 NE Third Avenue, Ste. 1500
Ft. Lauderdale, FL. 33301, USA.
www.trifecta-pharma.com
Questions
Call 1-888-296-9067
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