24909-119 terrasil Balanitis Relief Ointment

Manufacturer: Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions
Effective date: 2024-11-20
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 02:29:01

Label at a glance#

ProductTerrasil Balanitis Relief

Active ingredientSULFUR, SYMPHYTUM OFFICINALE WHOLE

Label structure8 sections

Indications and uses

Helps relieve irritated skin at the head of the penis.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area 2 to 3 times per day or as needed. Children under 2 years of age: Consult a doctor. Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur 1X HPUS
Symphytum Officinale (Comfrey) 1X HPUS

Purpose

OTC - PURPOSE SECTION

Sulfur - Rash Relief
Symphytum Officinale - Inflammatory Relief

Uses

INDICATIONS & USAGE SECTION

Helps relieve irritated skin at the head of the penis.

Warnings

WARNINGS SECTION

For external use only. When using this product do not use in or near eyes. Stop use and ask a doctor if symptoms last more than 3 days, symptoms worsen, or symptoms clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, call Poison Control or seek medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Inactive Ingredients

INACTIVE INGREDIENT SECTION

allantoin, beeswax, cedarwood oil, cottonseed oil, jojoba oil, lavender oil, magnesium oxide, MCT Oil, silver stearate, zinc oxide.

PRINCIPAL DISPLAY PANEL - 14g & 50g Tubes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24909-119-14	Terrasil Balanitis Relief	14 g in 1 JAR	OINTMENT	14	4
24909-119-15	Terrasil Balanitis Relief	14 g in 1 TUBE	OINTMENT	14	4
24909-119-28	Terrasil Balanitis Relief	28 g in 1 TUBE	OINTMENT	28	4
24909-119-44	Terrasil Balanitis Relief	44 g in 1 JAR	OINTMENT	44	4
24909-119-50	Terrasil Balanitis Relief	50 g in 1 TUBE	OINTMENT	50	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24909-119	TERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SCIENTIFIC, INC., DBA AIDANCE SKINCARE & TOPICAL SOLUTIONS]	4	Current NDC, Legacy NDC, 5 package rows	20241123_16c243e0-dec4-4643-949f-48dfd6bc5c08.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	1
SYMPHYTUM OFFICINALE WHOLE	ACTIVE INGREDIENT	H8FJJ6KX5Y	1
SULFUR	ACTIVE MOIETY	70FD1KFU70	1
SYMPHYTUM OFFICINALE WHOLE	ACTIVE MOIETY	H8FJJ6KX5Y	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	1
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	1
CEDRUS ATLANTICA BARK OIL	INACTIVE INGREDIENT	ZX5QRE4U60	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	1
SILVER OXIDE	INACTIVE INGREDIENT	897WUN6G6T	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 · 14 matching rows.

Terrasil Balanitis Relief
Sulfur, Symphytum Officinale (Comfrey)
ALLANTOIN
CEDRUS ATLANTICA BARK OIL
MEDIUM-CHAIN TRIGLYCERIDES
COTTONSEED OIL
JOJOBA OIL
LAVENDER OIL
MAGNESIUM OXIDE
SILVER STEARATE
WHITE WAX
ZINC OXIDE
SULFUR
SYMPHYTUM OFFICINALE WHOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
24909-119	24909-119-14, 24909-119-44, 24909-119-15, 24909-119-50, 24909-119-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALLANTOIN	344S277G0Z	IACT
CEDRUS ATLANTICA BARK OIL	ZX5QRE4U60	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
COTTONSEED OIL	H3E878020N	IACT
JOJOBA OIL	724GKU717M	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
MAGNESIUM OXIDE	3A3U0GI71G	IACT
SILVER STEARATE	4H6PCL92ZN	IACT
WHITE WAX	7G1J5DA97F	IACT
ZINC OXIDE	SOI2LOH54Z	IACT
SULFUR	70FD1KFU70	ACTIB
SYMPHYTUM OFFICINALE WHOLE	H8FJJ6KX5Y	ACTIB

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 · 108 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BENTONITE	BENTONITE	A3N5ZCN45C	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	CREAM / TOPICAL	4.1 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	CREAM / TOPICAL	4.1 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER / TOPICAL	0.67 mg/mg		Exact identifier — unii+route 24 equally ranked IID candidates
ALLANTOIN	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii+route 6 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, DELAYED RELEASE / ORAL		368 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, FILM COATED / ORAL		80 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	OINTMENT / TOPICAL	14.75 %w/w		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER / TOPICAL	0.67 mg/mg		Exact identifier — unii+route 24 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	LOTION / TOPICAL	16 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, EXTENDED RELEASE / ORAL		75 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	CREAM / TOPICAL	4.1 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET / ORAL		63 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
ALLANTOIN	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii+route 6 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, DELAYED RELEASE / ORAL		368 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	GUM, CHEWING / BUCCAL		173 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, EXTENDED RELEASE / ORAL		75 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, EXTENDED RELEASE / ORAL	25.74 mg		Exact identifier — unii candidate 54 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	LOTION / TOPICAL	16 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	OINTMENT / TOPICAL	14.75 %w/w		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT / TOPICAL		2100 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER / TOPICAL	0.67 mg/mg		Exact identifier — unii+route 24 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET / ORAL		63 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER / TOPICAL	0.67 mg/mg		Exact identifier — unii+route 24 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	CREAM / TOPICAL	4.1 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	GUM, CHEWING / BUCCAL		173 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, EXTENDED RELEASE / ORAL	25.74 mg		Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, EXTENDED RELEASE / ORAL	25.74 mg		Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, DELAYED RELEASE / ORAL		78 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	OINTMENT / TOPICAL	14.75 %w/w		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET / SUBLINGUAL		15 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
ALLANTOIN	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii+route 6 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET / SUBLINGUAL		15 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, DELAYED RELEASE / ORAL		78 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	OINTMENT / TOPICAL	14.75 %w/w		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER / TOPICAL	0.67 mg/mg		Exact identifier — unii+route 24 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	GUM, CHEWING / BUCCAL		173 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, FILM COATED / ORAL		80 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, EXTENDED RELEASE / ORAL		75 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, FILM COATED / ORAL		80 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	GUM, CHEWING / BUCCAL		173 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE / ORAL		20 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, DELAYED RELEASE / ORAL		368 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SHAMPOO, SUSPENSION / TOPICAL	3.25 %w/v		Exact identifier — unii+route 24 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SHAMPOO, SUSPENSION / TOPICAL	3.25 %w/v		Exact identifier — unii+route 24 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, EXTENDED RELEASE / ORAL	25.74 mg		Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, EXTENDED RELEASE / ORAL		75 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE / ORAL		20 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, DELAYED RELEASE / ORAL		78 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE / ORAL		20 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, DELAYED RELEASE / ORAL		368 mg	Exact identifier — unii candidate 54 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT / TOPICAL		2100 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SHAMPOO, SUSPENSION / TOPICAL	3.25 %w/v		Exact identifier — unii+route 24 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	LOTION / TOPICAL	5 %w/w		Exact identifier — unii+route 24 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
Terrasil Balanitis Relief	SULFUR, SYMPHYTUM OFFICINALE (COMFREY)	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	16c243e0-dec4-4643-949f-48dfd6bc5c08	2024-11-20	Warnings	Exact identifier ndc (package): 24909-119-15 ndc (package): 24909-119-28 ndc (package): 24909-119-44 ndc (package): 24909-119-50 ndc (package): 24909-119-14 ndc (product): 24909-119 ndc11 (package): 24909011914 ndc11 (package): 24909011915 ndc11 (package): 24909011928 ndc11 (package): 24909011950 ndc11 (package): 24909011944 spl id: 2763f0a0-abfe-19d4-e063-6394a90a1a7e spl set id: 16c243e0-dec4-4643-949f-48dfd6bc5c08

Reported adverse events (FAERS/openFDA)#

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