Active Ingredient
White Petrolatum 100%
White Petrolatum Ointment
FDA Label NDC 69396-114
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 Llc for the product White Petrolatum (NDC 69396-114). 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, stop use and ask a doctor, keep out of reach of children, when using this product, do not use, 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
Temporarily protects and relieves
- minor cuts
- scrapes
- burns
- chapped or cracked skin and lips
Stop Use And Ask A Doctor
Condition worsens
Symptoms last more than 7 days or clear up and occur again with a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
When Using This Product
Avoid contact with eyes
Do Not Use
- On deep or puncture wounds
- Animal Bites
- Serious Burns
Directions
Apply as needed
Inactive Ingredients
mineral oil, vitamin A Palmitate, vitamin D3, Microcrystalline Wax, Paraffin
Other
Distributed By
Trifecta Pharmaceuticals USA
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301
www.trifecta-pharma.com
1-888-296-9067
Warnings
For external use only
Questions
Call: 1-888-296-9067
Storage And Handling
Store at room temperature 20°-25°C (68°-77°F)
Tamper evident, do not use if packet is torn, cut or opened
Avoid excessive heat and humidity
* Please review the disclaimer below.
