Shea Butter Petroleum Jelly
FDA Label NDC 30400-501

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 Shea Butter Petroleum Jelly (NDC 30400-501). 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

Active Ingredient

White Petrolatum USP (99.6%)

Purpose

Skin Protectant

Uses

temporarily protects minor: cuts, scrapes, burns; temporarily protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather

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 longer than 7 days or clear up and occur again within 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 Ingredients

butyrospermum parkii (shea butter), fragrance

Questions Or Comments?

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