Blistex
FDA Label NDC 10157-9825

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blistex Inc for the product Blistex (NDC 10157-9825). 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 otc - active ingredient, otc - purpose, otc - when using, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Petrolatum

Hemosalate

Octinoxate

Oxybenzone

Octisalate

Otc - Purpose

SKIN PROTECTANT/ SUNSCREEN

Otc - When Using

  • Temporarily protects and helps relieve chapped or cracked lips

    • Helps protect lips from the drying effects of wind, cold weather
      • Helps prevent sunburn

        • FOR EXTERNAL USE ONLY


        • Do not use on * deep puncture wounds* animal bites* serious burns
        • Stop use if skin rash occurs
        • Adults and children 2 years of age and older: apply liberally to affected area not more than 3 to 4 times daily.
        • Children under 2 years of age : consult a doctor.


Package Label.Principal Display Panel



BLISTEX

FIVE STAR
LIP PROTECTION


  • Holds in moisture in Dry air
  • Soothes cold chapped lips
  • Rehydrates heat stressed lips
  • Forms a wind resistant  moisture shield
  • UVA/UVB sun protection

    • NET WT. .15oz. (4.25g)   SPF











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