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  5. Label Information: Terrasil Cold Sore Treatment

FDA Label for Terrasil Cold Sore Treatment

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Terrasil Cold Sore Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Aidance Skincare & Topical Solutions, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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