Terrasil Cold Sore Treatment
FDA Label NDC 24909-109

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aidance Skincare & Topical Solutions, Llc for the product Terrasil Cold Sore Treatment (NDC 24909-109). 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, keep out of reach of children., directions, inactive ingredients, 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

Active Ingredient

Allantoin 0.5%, Benzalkonium Chloride 0.1%

Purpose

Allantoin - Skin Protectant
Benzalkonium Chloride - Cold sore / fever blister treatment; Topical Antiseptic

Uses

  • To treat cold sores / fever blisters.
  • To help guard against infection. 

Warnings

For external use only.

Do not use
  • in the eyes
  • over large areas of the body
  • if you are allergic to any ingredient in this product
  • longer than one week unless directed by doctor.
    • Stop use and ask doctor if condition persists or worsens symptoms persist for more than 7 days.

    Ask a doctor if used to treat deep or puncture wounds, animal bites or serious burns, you are pregnant or nursing.

    When using this product you may feel a brief stinging sensation when you apply it. The stinging should go away in short time.



Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control center right away.

Directions

Adults and children 12 years or over: Wash hands before and after applying Terrasil. Apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle). Early treatment ensures the best results. Rub in gently but completely. Do not use more than 3 times a day. Children under 12 years: ask a doctor. Store at room temperature.

Inactive Ingredients

bentonite, cera alba (organic beeswax), magnesium oxide, palmarosa oil, peppermint oil, silver oxide, simmondsia chinensis (jojoba) seed oil, zinc oxide



Package Label.Principal Display Panel

Jar Label (Terrasil Cs Reg Label 14g 040212)

Jar Label (Terrasil Cs Reg Label 14g 040212)

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