Terrasil Cold Sore Treatment Max (Allantoin 1.0%, Lidocaine 1.0%) Ointment [Aidance Skincare & Topical Solutions, Llc] -

TERRASIL COLD SORE TREATMENT MAX (ALLANTOIN 1.0%, LIDOCAINE 1.0%) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC	24909-110-14
Set ID	9bae6163-1f18-4c25-b6fe-cc873153de01
Category	HUMAN OTC DRUG LABEL
Packager	Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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Active Ingredient

Allantoin 1.0%, Lidocaine 1.0%
Purpose

Allantoin - Skin Protectant
Lidocaine - Topical Anesthetic
Uses

Treats fever blisters and cold sores on the face or lips.
For the temporary relief of pain and itching.
Relieves dryness and softens cold sores and fever blisters.
Softens crusts (scabs) which may be associated with cold sores and fever blisters.
Warnings

For external use only. Do not use in or near the eyes. Avoid applying directly inside your mouth. Do not share this product with anyone. This may spread infection. Stop use and ask a doctor if: your cold sore gets worse or the cold sore is not healed within 10 days.

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. Use 3-5 times a day until healed. Children under 12 years: ask a doctor. Store at room temperature.
Inactive Ingredients

(organic) beeswax, bentonite, 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 MAX
allantoin 1.0%, lidocaine 1.0% ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	1 g in 100 g
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	1 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-110-14	14 g in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/01/2012

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture, label

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