Active Ingredient
Allantoin 1.0%, Lidocaine 1.0%
Terrasil Cold Sore Treatment
FDA Label NDC 24909-110
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 24909-110). 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
Purpose
Allantoin - Skin Protectant
Lidocaine - Topical Anesthetic
Uses
Treats fever blisters and cold sores on the face or lips.
For the temporary relief of pain and itching.
Relieves dryness and softens cold sores and fever blisters.
Softens crusts (scabs) which may be associated with cold sores and fever blisters.
Warnings
For external use only. Do not use in or near the eyes. Avoid applying directly inside your mouth. Do not share this product with anyone. This may spread infection. Stop use and ask a doctor if: your cold sore gets worse or the cold sore is not healed within 10 days.
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. Use 3-5 times a day until healed. Children under 12 years: ask a doctor. Store at room temperature.
Inactive Ingredients
(organic) beeswax, bentonite, magnesium oxide, palmarosa oil, peppermint oil, silver oxide, simmondsia chinensis (jojoba) seed oil, zinc oxide
Package Label.Principal Display Panel
Jar Label (Terrasil Cs Mx Label 02012012)
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