Terrasil Fissures Formula - Aidance Skincare & Topical Solutions, LLC

Manufacturer: Aidance Skincare & Topical Solutions, LLC
Effective date: 2014-06-10
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:39:54

Label at a glance#

ProductTerrasil Fissures Formula

Active ingredientCOCOA BUTTER

Label structure7 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cocoa Butter 50%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

terrasil with Activated Minerals

Fissures Formula
Coats. Soothes. Protects.

Jar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1544477	cocoa butter 50 % Topical Ointment	PSN	1
1544477	cocoa butter 0.5 MG/MG Topical Ointment	SCD	1
1544477	cocoa butter 50 % Topical Ointment	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24909-118-14	2020-01-31	C162847	48780-1	9d75b9d0-3178-f424-e053-dadaa90a57ce	Drug Facts
24909-118-44	2020-01-31	C162847	48780-1	9d75b9d0-3178-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24909-118-14	Terrasil Fissures Formula	14 g in 1 JAR	OINTMENT	14		1
24909-118-44	Terrasil Fissures Formula	44 g in 1 JAR	OINTMENT	44		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24909-118	TERRASIL FISSURES FORMULA (COCOA BUTTER) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]	1	Legacy NDC, 2 package rows	20140801_ecc98f3c-8df7-45ef-b4a8-4380aa31aa55.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
COCOA BUTTER	ACTIVE INGREDIENT	512OYT1CRR	1
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	1
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	1
SILVER OXIDE	INACTIVE INGREDIENT	897WUN6G6T	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	1
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Terrasil Fissures Formula
Cocoa Butter
BENTONITE
CALENDULA OFFICINALIS FLOWER
CHAMOMILE
JOJOBA OIL
MAGNESIUM OXIDE
PEPPERMINT OIL
SILVER OXIDE
TEA TREE OIL
WHITE WAX
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
24909-118	24909-118-14, 24909-118-44

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COCOA BUTTER	512OYT1CRR	ACTIB
BENTONITE	A3N5ZCN45C	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	IACT
CHAMOMILE	FGL3685T2X	IACT
JOJOBA OIL	724GKU717M	IACT
MAGNESIUM OXIDE	3A3U0GI71G	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
SILVER OXIDE	897WUN6G6T	IACT
TEA TREE OIL	VIF565UC2G	IACT
WHITE WAX	7G1J5DA97F	IACT
ZINC OXIDE	SOI2LOH54Z	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 62 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, FILM COATED / ORAL		80 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SYSTEM / TRANSDERMAL	9.86 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	POWDER / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	SUPPOSITORY / RECTAL	265 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SUPPOSITORY / RECTAL	375 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	TABLET / ORAL	355 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET / SUBLINGUAL		15 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SOLUTION / RESPIRATORY (INHALATION)	3.11 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / BUCCAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SUSPENSION / ORAL	100 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	INJECTION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET / ORAL		63 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SOLUTION / INTRAVENOUS	3.11 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, DELAYED RELEASE / ORAL		368 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, DELAYED RELEASE / ORAL		78 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE / ORAL		79 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CONCENTRATE / ORAL	0.05 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, EXTENDED RELEASE / ORAL	25.74 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, EXTENDED RELEASE / ORAL	14 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, DELAYED RELEASE / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SOLUTION / DENTAL	0.04 %v/v		Exact identifier — unii candidate 21 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT, AUGMENTED / TOPICAL		429 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT / TOPICAL		2100 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	PASTE, DENTIFRICE / DENTAL	49.3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER, DENTIFRICE / DENTAL	0.05 mg/mg		Exact identifier — unii candidate 11 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / VAGINAL		40 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SUPPOSITORY / VAGINAL	288.1 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	GUM, CHEWING / BUCCAL		173 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	AEROSOL, FOAM / TOPICAL	2 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, EXTENDED RELEASE / ORAL		75 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM, AUGMENTED / TOPICAL	10 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SUSPENSION / ORAL	65 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	INJECTION, SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER / TOPICAL	0.67 mg/mg		Exact identifier — unii candidate 11 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CAPSULE / ORAL		60 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	TABLET, COATED / ORAL	1.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET / ORAL	5 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / ORAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SHAMPOO, SUSPENSION / TOPICAL	3.25 %w/v		Exact identifier — unii candidate 11 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / SUBLINGUAL	0.15 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	LOZENGE / ORAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SPRAY, METERED / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	LOTION / TOPICAL	16 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SOLUTION / ORAL		53 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	CREAM / TOPICAL	4.1 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	FILM / BUCCAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	CAPSULE / ORAL	ADJ PH		Exact identifier — unii candidate 11 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, COATED / ORAL	3 mg		Exact identifier — unii candidate 15 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3a18e0c8-29a5-4b65-a9e0-f0c265a4d78d			ecc98f3c-8df7-45ef-b4a8-4380aa31aa55	2014-06-10	Warnings	Exact identifier spl id: 3a18e0c8-29a5-4b65-a9e0-f0c265a4d78d spl set id: ecc98f3c-8df7-45ef-b4a8-4380aa31aa55

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.