Ichthammol Ointment 20%

Manufacturer: TRIFECTA PHARMACEUTICALS USA LLC | Trifecta Pharmaceuticals USA
Effective date: 2024-12-31
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 02:29:55

Label at a glance#

ProductIchthammol 20%

Active ingredientICHTHAMMOL

Label structure9 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.

Contacts and useful links#

PhoneLabel contact1-888-296-9067

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.

Before using any medication, read all label directions.

Keep this carton, it contains important information.

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:

Trifecta Pharmaceuticals USA ^TM

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

1-888-296-9067

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4015 GLOBE ICHTHAMMOL OINTMENT 20 PERCENT 1OZ REV06 052223 CDER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69396-004-20	Ichthammol 20%	28.3 g in 1 TUBE	OINTMENT	28.3		12
69396-004-20	Ichthammol 20%	1 in 1 BOX	OINTMENT	1		12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-004	ICHTHAMMOL 20% (ICHTHAMMOL) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]	12	Current NDC, Legacy NDC, 2 package rows	20250101_9698b98c-bca1-4a7e-8a67-05d2a2b770a5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69396-004-20	GM - Gram	69396-004	3f60d637-d5ac-42a4-a0c1-3959c67cd32a	1	2018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ICHTHAMMOL	ACTIVE INGREDIENT	NQ14646378	4
ICHTHAMMOL	ACTIVE MOIETY	NQ14646378	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	4

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

Ichthammol 20%
Ichthammol
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69396-004	69396-004-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ICHTHAMMOL	NQ14646378	ACTIB
PETROLATUM	4T6H12BN9U	IACT

Source Document#

Source XML · Source PDF

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 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route+dosage form 2 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
Ichthammol 20%	ICHTHAMMOL	TRIFECTA PHARMACEUTICALS USA LLC	9698b98c-bca1-4a7e-8a67-05d2a2b770a5	2024-12-31	Warnings	Exact identifier ndc (package): 69396-004-20 ndc (product): 69396-004 ndc11 (package): 69396000420 spl id: 2a924831-5b30-7079-e063-6294a90a6806 spl set id: 9698b98c-bca1-4a7e-8a67-05d2a2b770a5

Reported adverse events (FAERS/openFDA)#

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