Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 4cc45fa7-631f-4d0a-9310-cf2e0885d4a0
Route
TOPICAL
Published
Effective Date 2012-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 g) Benzalkonium (0.1 g)
Inactive Ingredients
Bentonite Jojoba Oil Magnesium Oxide Palmarosa Oil Peppermint Oil Silver Oxide White Wax Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-09-07

Description

Allantoin 0.5%, Benzalkonium Chloride 0.1%

Purpose

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


Medication Information

Purpose

Allantoin - Skin Protectant

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

Description

Allantoin 0.5%, Benzalkonium Chloride 0.1%

Uses
  • To treat cold sores / fever blisters.

  • To help guard against infection. 
Section 51945-4

.

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.







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.

Active Ingredient

Allantoin 0.5%, Benzalkonium Chloride 0.1%

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





Keep Out of Reach of Children.

If swallowed, get medical help or contact a poison control center right away.


Structured Label Content

Uses
  • To treat cold sores / fever blisters.

  • To help guard against infection. 
Section 51945-4 (51945-4)

.

Purpose

Allantoin - Skin Protectant

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

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.







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.

Active Ingredient

Allantoin 0.5%, Benzalkonium Chloride 0.1%

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





Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

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