Petrocort Antipruritic Lip 21 Lipstick
FDA Label NDC 51822-021

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Clinical Formula Llc for the product Petrocort Antipruritic Lip 21 (NDC 51822-021). 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 (in percentage), purpose, uses:, warnings:, keep out of reach of children., directions:, inactive ingredients:, package labeling:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Percentage)

Hydrocortisone 0.5%

Purpose

For relief of minor skin irritation.

Uses:

Adults and children 5 years and over: For the temporary relief of minor skin irritations and rashes. Help prevent and temporarily protect chafed, chapped, cracked, windburned or sunburned lips.

Warnings:

For external use only. If condition worsens, does not improve, or symptoms persist for more than 7 days or clear up and reoccur again within a few days, discontinue use and consult a physician. Keep from heat.

Keep Out Of Reach Of Children.

Directions:

Apply to lips 1-3 times daily or use as directed by physician. For use on children under 5 years of age, consult a physician.

Inactive Ingredients:

Petrolatum, Syncrowax HGL-C, Syncorwax ERL-C, Padimate-O Mineral Oil, Propylparaben, Fragrance, FD & C Yellow # 5, FD & C Blue # 1.

Package Labeling:

Label (Label)

Label (Label)

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