TERRASIL COLD SORE TREATMENT- allantoin, benzalkonium chloride ointment

Drug Labeling and Warnings

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

TERRASIL COLD SORE TREATMENT 
allantoin, benzalkonium chloride ointment

Product 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)