FDA.reportPublic FDA data

CALENDULA OFFICINALIS FLOWER - Aidance Skincare & Topical Solutions, LLC

Manufacturer
Aidance Skincare & Topical Solutions, LLC
Effective date
2017-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:51

Label at a glance#

ProductFastrin Incontinence and Ostomy Rash Care
Active ingredientCALENDULA OFFICINALIS FLOWER, COMFREY, THUJA OCCIDENTALIS WHOLE
Label structure7 sections

Indications and uses

Helps relieve and prevent rashes and irritation due to wetness from incontinence. Helps prevent infection.

Dosage and administration

Clean and dry affected skin. Apply a thin layer of ointment over the affected area. Repeat 1 to 3 times daily or as needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calendula officinalis 1X HPUS, Comfrey (Symphytum officinale) 1X HPUS, Thuja occidentalis 3X HPUS

Purpose

OTC - PURPOSE SECTION

Calendula - Healing Agent, Comfrey - Anti-Inflammatory, Thuja - Irritation Relief

Uses

INDICATIONS & USAGE SECTION

Helps relieve and prevent rashes and irritation due to wetness from incontinence. Helps prevent infection.

Warnings

WARNINGS SECTION

For external use only. Do not get into eyes.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Clean and dry affected skin. Apply a thin layer of ointment over the affected area. Repeat 1 to 3 times daily or as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Cottonseed Oil, Jojoba Seed Oil, Magnesium Oxide, Manuka Honey, Peppermint Oil, Silver Oxide, Tea Tree Oil, Zinc Oxide

PRINCIPAL DISPLAY PANEL - 50g Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fastrin

Incontinence & Ostomy

Rash Care Ointment

Net WT 50g (1.76 oz.)

Tube LabelTube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24909-603-102020-01-31C16284748780-19d75b9d0-3271-f424-e053-dadaa90a57ceDrug Facts
24909-603-502020-01-31C16284748780-19d75b9d0-3271-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24909-603-10Fastrin Incontinence and Ostomy Rash Care10 g in 1 JAROINTMENT101
24909-603-50Fastrin Incontinence and Ostomy Rash Care50 g in 1 TUBEOINTMENT501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24909-603FASTRIN INCONTINENCE AND OSTOMY RASH CARE (CALENDULA, COMFREY, THUJA OCCIDENTALIS) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1Legacy NDC, 2 package rows20170707_3af07373-2bbc-4428-bb63-4313dc1dd8b5.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24909-60324909-603-10, 24909-603-50

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
NameUNIIKind
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
COMFREYD05HXK6R3GACTIB
THUJA OCCIDENTALIS WHOLE5HBV6WCE3NACTIB
COTTONSEED OILH3E878020NIACT
HONEYY9H1V576FHIACT
JOJOBA OIL724GKU717MIACT
MAGNESIUM OXIDE3A3U0GI71GIACT
PEPPERMINT OILAV092KU4JHIACT
SILVER OXIDE897WUN6G6TIACT
TEA TREE OILVIF565UC2GIACT
WHITE WAX7G1J5DA97FIACT
ZINC OXIDESOI2LOH54ZIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
47fa88a4-4774-4a84-a647-05bbde954fff3af07373-2bbc-4428-bb63-4313dc1dd8b52017-06-01WarningsExact identifier
spl id: 47fa88a4-4774-4a84-a647-05bbde954fff
spl set id: 3af07373-2bbc-4428-bb63-4313dc1dd8b5

Reported adverse events (FAERS/openFDA)#

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