Medicated Lip Balm
FDA Label NDC 0363-6080

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co for the product Medicated Lip Balm (NDC 0363-6080). 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 ingredients, purpose, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Camphor, 1.7%

Menthol, 0.7%

Phenol, 0.4%

Purpose

External Analgesic

Uses

  • temporarily relieves pain and itching commonly associated with fever blisters and cold sores

Warnings

For external use only

Directions

  • adults and children 2 years of age and older, apply to lips not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Inactive Ingredients

Alum, beeswax, cocoa butter, flavor, lanolin, petrolatum, salicylic acid

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