Active Ingredient
White Petrolatum 100%
White Petrolatum Ointment
FDA Label NDC 0404-0169
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein for the product White Petrolatum (NDC 0404-0169). 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, use(s), warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Use(S)
• Temporarily protects minor cuts, scrapes, and burns
• Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips
• Helps prevent and protect from the drying effects of wind and cold weather
• Protects chafed skin due to diaper rash
Warnings
For External Use Only
Do Not Use On
• Deep or puncture wounds
• Animal bites
• Serious burns
When Using This Product
Avoid contact with 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
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
• For other uses: Apply as needed.
Other Information
• Store at room temperature 15°-30°C (59°-86°F)
• Avoid excessive heat
• Tamper evident. Do not use if packet is torn, cut, or opened.
Label
570-3127 Petrolatum Ointment
* Please review the disclaimer below.
