Active Ingredient
White Petrolatum (USP, 100% w/w)
White Petrolatum Jelly
FDA Label NDC 68786-211
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sion Biotext Medical Ltd for the product White Petrolatum (NDC 68786-211). 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:, warnings:, when using this product, stop use and ask a doctor if, do not use on, 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
Uses:
- Helps treat and prevent diaper rash
- Helps seal out wetness
- Temporarily protects minor * cuts * scrapes * burns
- Temporarily helps protect and relieve chapped and cracked skin or lips
- Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
- With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged.
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 in a few days.
Do Not Use On
- deep 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.
Directions:
- Change wet and soiled diapers promptly.
- Cleanse the diaper area and allow to dry.
- Apply as needed.
Other Information:
- Store at 59 Deg F - 86 Deg F (15 - 30 Deg C)
- Avoid excessive heat.
Principal Display Panel
WHITE PETROLATUM (USP)
SKIN PROTECTANT
Made in Israel
* Please review the disclaimer below.
