TERRASIL BOIL PAIN RELIEF- benzocaine 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

Benzocaine 3.5%

Purpose

Pain Reliever

Uses

For the temporary relief of pain and discomfort caused by boils.

Warnings

For external use only. Do not use for more than 3 days. Ask a doctor before use if you have boils on the lips, nose, cheeks, or forehead. When using this product avoid contact with the eyes. Stop use and ask a doctor if - fever occurs, - redness around the boil develops, - condition worsens or does not improve, - symptoms persist for more than 3 days, - symptoms clear up and occur again within a few days.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Apply to affected area no more than 2 times daily. Children under 2 years of age: Consult a doctor. Store at room temperature. May stain fabrics.

Inactive Ingredients

beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, silver oxide, tea tree oil, turmeric, zinc oxide.

PRINCIPAL DISPLAY PANEL - 44g Label

terrasil with Activated Minerals

Boil Pain Relief
Fast. Powerful. Relief.

Jar Label

TERRASIL BOIL PAIN RELIEF 
benzocaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
JOJOBA OIL (UNII: 724GKU717M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SILVER OXIDE (UNII: 897WUN6G6T)  
TEA TREE OIL (UNII: VIF565UC2G)  
TURMERIC (UNII: 856YO1Z64F)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-120-1414 g in 1 JAR
2NDC:24909-120-4444 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/20/2014
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-120) , label(24909-120)

Revised: 6/2014
Document Id: 9737ce92-19b4-4933-8c34-ad1d0891998e
Set id: 30816167-0876-433f-8cae-c075bcc5c9d9
Version: 1
Effective Time: 20140620
 
Aidance Skincare & Topical Solutions, LLC