Active Ingredient
White Petrolatum USP (99%)
Cocoa Butter Petroleum Jelly
FDA Label NDC 30400-503
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jell Pharmaceuticals Pvt. Ltd. for the product Cocoa Butter Petroleum Jelly (NDC 30400-503). 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, otc - do not use, otc - when using, otc - stop use, otc - 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
• For the temporary protection of minor cuts, scrapes, burns
• Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.
Warnings
For External Use Only
Otc - Do Not Use
Do not use on deep puncture wounds, animal bites, or serious burns. Ask a doctor.
Otc - When Using
When using this product avoid contact with eyes.
Otc - Stop Use
Stop use and ask doctor if condition worsens or does not improve within 7 days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children if swallowed get medical help or contact a Poison Control Center right away.
Directions
apply product liberally, as often as necessary.
Inactive Ingredients
Theobroma Cacao (Cocoa) Seed Butter, fragrance
* Please review the disclaimer below.
