Label: TERRASIL COLD SORE TREATMENT- allantoin, benzalkonium chloride ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 24909-109-14 - Packager: Aidance Skincare & Topical Solutions, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 5, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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.
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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TERRASIL COLD SORE TREATMENT
allantoin, benzalkonium chloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.5 g in 100 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) JOJOBA OIL (UNII: 724GKU717M) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) PALMAROSA OIL (UNII: 0J3G3O53ST) PEPPERMINT OIL (UNII: AV092KU4JH) SILVER OXIDE (UNII: 897WUN6G6T) WHITE WAX (UNII: 7G1J5DA97F) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-109-14 14 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/07/2012 Labeler - Aidance Skincare & Topical Solutions, LLC (018950611) Establishment Name Address ID/FEI Business Operations Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-109) , label(24909-109)