TERRASIL WOUND CARE - allantoin, benzethonium chloride ointment 
Aidance Skincare & Topical Solutions, LLC

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.

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Drug Facts

Active Ingredient

Allantoin 0.5%

Benzethonium Chloride 0.1%

Purpose

Allantoin - Skin Protectant

Benzethonium Chloride - Antiseptic

Uses

Warnings

For external use only.
When using this product, do not get into eyes.
Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.
Do not use on deep or puncture wounds, animal bites or serious burns.

Keep out of reach of children.

If swallowed, call poison control or seek medical help.

Directions

Wash and dry affected skin. Apply a thin layer of Terrasil. Cover affected area with a clean bandage. Repeat procedure 2-3 times daily until skin improves. Store at room temperature.

Inactive Ingredients

bentonite, cera alba (organic beeswax), magnesium oxide, peppermint oil, sage oil, silver oxide, simmondsia chinensis (jojoba) seed oil, tea tree oil, zinc oxide

PRINCIPAL DISPLAY PANEL - 14g Label

Jar Label

TERRASIL WOUND CARE 
allantoin, benzethonium chloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WHITE WAX (UNII: 7G1J5DA97F)  
BENTONITE (UNII: A3N5ZCN45C)  
JOJOBA OIL (UNII: 724GKU717M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SAGE OIL (UNII: U27K0H1H2O)  
SILVER OXIDE (UNII: 897WUN6G6T)  
TEA TREE OIL (UNII: VIF565UC2G)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-117-1414 g in 1 JAR
2NDC:24909-117-4444 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34709/07/2012
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-117) , label(24909-117)

Revised: 9/2012
Document Id: f076c392-c3a0-4938-90a9-1f77611fff61
Set id: a6c1be44-4122-4521-8129-860c6a34ad3f
Version: 2
Effective Time: 20120905
 
Aidance Skincare & Topical Solutions, LLC