TERRASIL FISSURES FORMULA- cocoa butter ointment

Drug Labeling and Warnings

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

TERRASIL FISSURES FORMULA 
cocoa butter ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	50 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-118-14	14 g in 1 JAR
2	NDC: 24909-118-44	44 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	06/10/2014

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-118) , label(24909-118)