Active Ingredient
White Petrolatum (100% w/w)
Pure Petrolatum Jelly
FDA Label NDC 85114-1010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Umendra Life Sciences Private Limited for the product Pure Petrolatum Jelly (NDC 85114-1010). 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
- temporarily protects minor cuts, scrapes, burns and sunburn
- temporarily protects and helps relieve chapped or cracked skin
- helps protect from the drying effects of wind and cold weather
- helps treat and prevent diaper rash
- helps seal out wetness
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 for more than 7 days or clean up and occur again in 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
Directions
- apply as needed
Inactive Ingredient
none
* Please review the disclaimer below.
