FDA.reportPublic FDA data

Ichthammol Ointment - Advanced Drawing Salve 20% Ichthammol - Homeopathic

Manufacturer
Chain Drug Marketing Association, Inc. | Trifecta Pharmaceuticals USA
Effective date
2023-05-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:21:17

Label at a glance#

ProductIchthammol 20%
Active ingredientICHTHAMMOL
Label structure10 sections

Dosage and administration

Cleanse affected area. Apply on gauze bandage once or twice a day. Repeat as necessary. Do not rub or massage affected area.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ichthammol 20%

Purpose

OTC - PURPOSE SECTION

Drawing Salve

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Suggested Use

INDICATIONS & USAGE SECTION

• Treating insect bites and stings from mosquitoes, spider, and bees • Removing splinters and silvers • Treating plant irritations, such as nettles or poison ivy • Treating minor skin infections such as an ingrown toenail • Soothing skin relief • Apply to minor skin irritations

Warnings

WARNINGS SECTION

• For external use only • Do not use in eyes • Ask a doctor before use if you have deep puncture wounds or serious burns • Stop use and ask doctor if redness, irritation, swelling or pain persists

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

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse affected area. Apply on gauze bandage once or twice a day. Repeat as necessary. Do not rub or massage affected area.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Petrolatum

SPL UNCLASSIFIED SECTION

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Other Information

SPL UNCLASSIFIED SECTION

Before using any medication, read all label directions

Keep this carton, it contains important information

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality Choice Ichthammol OintmentQuality Choice Ichthammol Ointment

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-458-102025-01-30C16284748780-1ba0f9c33-44dc-a910-e053-dadaa90a0b85Ichthammol Ointment - Advanced Drawing Salve 20% Ichthammol - Homeopathic
63868-458-102023-05-23C16284748780-1ba0f9c33-44dc-a910-e053-dadaa90a0b85Ichthammol Ointment - Advanced Drawing Salve 20% Ichthammol - Homeopathic
63868-458-102023-01-30C16284748780-1ba0f9c33-44dc-a910-e053-dadaa90a0b85Ichthammol Ointment - Advanced Drawing Salve 20% Ichthammol - Homeopathic
63868-458-102021-02-10C16284748780-1ba0f9c33-44dc-a910-e053-dadaa90a0b85Ichthammol Ointment - Advanced Drawing Salve 20% Ichthammol - Homeopathic
63868-458-102021-01-29C16284748780-1ba0f9c33-44dc-a910-e053-dadaa90a0b85Ichthammol Ointment - Advanced Drawing Salve 20% Ichthammol - Homeopathic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-458-10Ichthammol 20%28.3 g in 1 TUBEOINTMENT28.33
63868-458-10Ichthammol 20%1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-458ICHTHAMMOL 20% (ICHTHAMMOL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION, INC.]3Legacy NDC, 2 package rows20230525_850136ef-8fd1-7c09-e053-2a91aa0a6abd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-458-10GM - Gram63868-4587075009f-3a25-452f-ba76-444f4a56ab7612023-02-06

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-45863868-458-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
ICHTHAMMOLNQ14646378ACTIB
LANOLIN7EV65EAW6HIACT

Source Document#

Source XML · Source PDF

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
fc61822a-3fbb-343c-e053-6294a90af72c850136ef-8fd1-7c09-e053-2a91aa0a6abd2023-05-23WarningsExact identifier
spl id: fc61822a-3fbb-343c-e053-6294a90af72c
spl set id: 850136ef-8fd1-7c09-e053-2a91aa0a6abd

Reported adverse events (FAERS/openFDA)#

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