FDA.reportPublic FDA data

Benzoin Compound Tincture

Manufacturer
Humco Holding Group, Inc. | Pharma Nobis, LLC
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:22:19

Label at a glance#

ProductBenzoin Compound Tincture
Active ingredientBENZOIN RESIN
Label structure14 sections

Dosage and administration

Adults and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more often than every 2 hours. Children under 6 months of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoin

Purpose

OTC - PURPOSE SECTION

Oral mucosal protectant

Use

INDICATIONS & USAGE SECTION

Forms a coating over wound for protecting recurring canker sores

Warnings

WARNINGS SECTION

For external use only. Do not swallow. Do not exceed recommended dosage.

When using this product

OTC - WHEN USING SECTION

Children under 12 years of age should be supervised in the use of this product.

Do not use for more than 7 days unless directed by a dentist or doctor.

Stop use and consult a dentist or doctor if

OTC - STOP USE SECTION

sore mouth symptoms do not improve in 7 days. irritation, pain or redness persists or worsens. swelling, rash or fever develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more often than every 2 hours.

Children under 6 months of age: Consult a dentist or doctor.

Other information

OTHER SAFETY INFORMATION

Flammable: Keep away from spark, heat or flame.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol 77%, Aloe, Storax, Tolu Balsam

Principal Display Panel - 16oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benz16.jpgBenz16.jpg16 oz16 oz

Principal Display Panel - 2 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benz.jpgBenz.jpg

new labelnew label

2 oz2 oz

2025 Label Update

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Humco Benzoin Compound 2025Humco Benzoin Compound 2025

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130303950243160GTIN-13: 0303950243160
EAN-13: 0303950243160
GTIN-12: 303950243160
UPC-A: 303950243160
GTIN storage (14 digits): 00303950243160		Benz16.jpg, L024316001-BENZOIN-COMPOUND-16OZ-Web.jpg
BarcodeEAN-130303950243924GTIN-13: 0303950243924
EAN-13: 0303950243924
GTIN-12: 303950243924
UPC-A: 303950243924
GTIN storage (14 digits): 00303950243924		L024392001-BENZOIN-COMPOUND-TR-2-OZ.-Web.jpg, Benz.jpg, DOC120817 (003).jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-0243-16Benzoin Compound Tincture473 mL in 1 BOTTLE, PLASTICLIQUID4737
0395-0243-92Benzoin Compound Tincture59 mL in 1 BOTTLE, PLASTICLIQUID597

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0243-16ML - Milliliter0395-02439a0811d7-af7f-4bc9-9bf4-0b4e83a5eef912013-10-17
0395-0243-92ML - Milliliter0395-0243b7ef01a6-f854-4be0-8215-1c72658733fc12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOIN RESINACTIVE INGREDIENTGK21SBA74R1
BENZOIN RESINACTIVE MOIETYGK21SBA74R1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALOEINACTIVE INGREDIENTV5VD430YW91
TOLU BALSAMINACTIVE INGREDIENTTD2LE91MBE1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-02430395-0243-16, 0395-0243-92

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ALOEV5VD430YW9IACT
TOLU BALSAMTD2LE91MBEIACT
BENZOIN RESINGK21SBA74RACTIB

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 1 · 45 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
45 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzoin Compound TinctureBENZOIN RESINHumco Holding Group, Inc.a893a232-2ea8-4e0d-8cbf-7f5040b3be2e2025-12-11WarningsExact identifier
ndc (package): 0395-0243-92
ndc (package): 0395-0243-16
ndc (product): 0395-0243
ndc11 (package): 00395024316
ndc11 (package): 00395024392
spl id: 45b3d3ef-3410-79a1-e063-6394a90a758d
spl set id: a893a232-2ea8-4e0d-8cbf-7f5040b3be2e

Reported adverse events (FAERS/openFDA)#

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