Blistex Ointment
FDA Label NDC 10157-9302

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 10157-9302). 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 other, otc - purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - do not 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

Other

Drug Facts

Otc - Purpose

Active ingredientsPurpose
Benzocaine 5.0% (w/w)External Analgesic
Chloroxylenol 0.1% (w/w)Antiseptic

Uses

  • For the temporary relief of pain associated with burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.
  • First aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

  • For external use only.

When Using This Product

  • Avoid contact with the eyes

Stop Use And Ask A Doctor If

  • condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Do Not Use

  • Do not apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

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

  • Clean the affected area.
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a physician.

Other Information

  • Avoid contact with clothing. Foille may stain certain fabrics.

Inactive Ingredients

beeswax, benzyl alcohol, calcium disodium EDTA, calcium hydroxide, ceresin, eugenol, hydrogenated vegetable oil, maleic anhydride, mono- and di-glycerides, PEG-32, purified water, sodium borate, sodium lauryl sulfate, zea mays (corn) oil.

Principal Display Panel - 28 G Tube Carton

NDC 10157-9302-4

Foille®
EXTERNAL ANALGESIC / ANTISEPTIC

MEDICATED
FIRST AID OINTMENT

Fast, Soothing Relief Of Pain Due To:
Cuts & Scrapes • Minor Burns
Sunburn • Insect Bites

NET WT.
1 oz (28g)

Principal Display Panel (28 g Tube Carton)

Principal Display Panel (28 g Tube Carton)

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