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Terrasil Cold Sore Treatment

Dosage form: ointment
Ingredients: ALLANTOIN 0.5g in 100g, BENZALKONIUM CHLORIDE 0.1g in 100g
Labeler: Aidance Skincare & Topical Solutions, LLC
NDC Code: 24909-109

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 Facts

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



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TERRASIL COLD SORE TREATMENT 
allantoin, benzalkonium chloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-109
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN0.5 g  in 100 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE 
JOJOBA OIL 
MAGNESIUM OXIDE 
PALMAROSA OIL 
PEPPERMINT OIL 
SILVER OXIDE 
WHITE WAX 
ZINC OXIDE 
Packaging
#Item CodePackage Description
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/FEIOperations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-109), label(24909-109)

Revised: 09/2012
Document Id: 86f31e92-c25a-465d-bb5b-cf63894a6866
Set id: 4cc45fa7-631f-4d0a-9310-cf2e0885d4a0
Version: 2
Effective Time: 20120905
 
Aidance Skincare & Topical Solutions, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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