FDA.reportPublic FDA data

Ichthammol 20%

Manufacturer
Chain Drug Marketing Association, Inc. | Trifecta Pharmaceuticals USA
Effective date
2024-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:27:30

Label at a glance#

ProductIchthammol 20%
Active ingredientICHTHAMMOL
Label structure11 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.

If swallowed, get medical help or contact a poison control center immediately.

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 •

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.

Stop Use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if redness , irritation, swelling or pain persists.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Petrolatum

SPL UNCLASSIFIED SECTION

Distributed by CDMA., Inc.©

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Other Information

SPL UNCLASSIFIED SECTION

Before using any medication, read all label directions

Store at room temperature

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

99739 QC ICHTHAMMOL OINTMENT 1OZ REV11 03042499739 QC ICHTHAMMOL OINTMENT 1OZ REV11 030424

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-048-01Ichthammol 20%28.3 g in 1 TUBEOINTMENT28.31
83324-048-01Ichthammol 20%1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-048ICHTHAMMOL 20% (ICHTHAMMOL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION, INC.]1Current NDC, 2 package rows20240709_1cc52246-bec4-2d44-e063-6394a90a625b.zip

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
83324-04883324-048-01

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
LANOLIN7EV65EAW6HIACT
ICHTHAMMOLNQ14646378ACTIB

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
Ichthammol 20%ICHTHAMMOLChain Drug Marketing Association, Inc.1cc52246-bec4-2d44-e063-6394a90a625b2024-07-08WarningsExact identifier
ndc (package): 83324-048-01
ndc (product): 83324-048
ndc11 (package): 83324004801
spl id: 1cc52258-5150-de0c-e063-6294a90ac035
spl set id: 1cc52246-bec4-2d44-e063-6394a90a625b

Reported adverse events (FAERS/openFDA)#

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