TERRASIL FISSURES FORMULA- cocoa butter 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.

----------

Drug Facts

Active Ingredient

Cocoa Butter 50%

Purpose

Skin Protectant

Uses

For the temporary relief of local itching and discomfort in the perianal area, associated with anorectal disorders. Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues. Temporarily protects irritated areas. Temporarily relieves burning.

Warnings

For external and/or intrarectal use only. When using this product do not exceed the recommended daily dosage unless directed by a doctor. Stop use and ask a doctor if - bleeding occurs - condition worsens or does not improve within 7 days. If pregnant or breast-feeding, ask a health professional before use. 

Keep out of reach of children.

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

Directions

Adults: If practical, cleanse the affected area before use. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. Regular use provides continual therapy for relief of symptoms. Children under 12 years of age: ask a doctor.

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL - 14g Label

terrasil with Activated Minerals

Fissures Formula
Coats. Soothes. Protects.

Jar Label

TERRASIL FISSURES FORMULA 
cocoa butter ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER50 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CHAMOMILE (UNII: FGL3685T2X)  
JOJOBA OIL (UNII: 724GKU717M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SILVER OXIDE (UNII: 897WUN6G6T)  
TEA TREE OIL (UNII: VIF565UC2G)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-118-1414 g in 1 JAR
2NDC:24909-118-4444 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/10/2014
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-118) , label(24909-118)

Revised: 6/2014
Document Id: 3a18e0c8-29a5-4b65-a9e0-f0c265a4d78d
Set id: ecc98f3c-8df7-45ef-b4a8-4380aa31aa55
Version: 1
Effective Time: 20140610
 
Aidance Skincare & Topical Solutions, LLC