TERRASIL COLD SORE TREATMENT - allantoin, benzalkonium chloride ointment 
Aidance Skincare & Topical Solutions, LLC

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.

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Drug Facts

Active Ingredient

Allantoin 0.5%, Benzalkonium Chloride 0.1%

Purpose

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

Uses

Warnings

For external use only.

Do not use

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



Jar Label.

TERRASIL COLD SORE TREATMENT 
allantoin, benzalkonium chloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-109-1414 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/07/2012
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-109) , label(24909-109)

Revised: 9/2012
Document Id: 86f31e92-c25a-465d-bb5b-cf63894a6866
Set id: 4cc45fa7-631f-4d0a-9310-cf2e0885d4a0
Version: 2
Effective Time: 20120905
 
Aidance Skincare & Topical Solutions, LLC