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

Purpose

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

Description

Allantoin 0.5%, Benzalkonium Chloride 0.1%


Medication Information

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.







Uses
  • To treat cold sores / fever blisters.

  • To help guard against infection. 
Purpose

Allantoin - Skin Protectant

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

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





Description

Allantoin 0.5%, Benzalkonium Chloride 0.1%

Section 51945-4

.

Active Ingredient

Allantoin 0.5%, Benzalkonium Chloride 0.1%

Keep Out of Reach of Children.

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


Structured Label Content

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.







Uses
  • To treat cold sores / fever blisters.

  • To help guard against infection. 
Purpose

Allantoin - Skin Protectant

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

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





Section 51945-4 (51945-4)

.

Active Ingredient

Allantoin 0.5%, Benzalkonium Chloride 0.1%

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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