FDA.reportPublic FDA data

Benz Protect

Manufacturer
Geritrex LLC
Effective date
2017-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:47

Label at a glance#

ProductBenz Protect
Active ingredientBENZOIN RESIN
Label structure10 sections

Dosage and administration

For adults and supervised children 2 years and older: Dry affected area of skin or oral mucosa. Apply with a cotton swab or gauze every 3-4 hours or as directed by your physician.

Storage and handling

Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature] in tight, light-resistant containers. Avoid exposure to direct sunlight or heat.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoin Compound Tincture (Benzoin, Aloe, Storax, Tolu, Balsam, Alcohol)

Intended Use

OTC - PURPOSE SECTION

  • Forms a coating over a wound
  • For protecting recurring canker sores

Directions

INDICATIONS & USAGE SECTION

For adults and supervised children 2 years and older:
Dry affected area of skin or oral mucosa. Apply with a cotton
swab or gauze every 3-4 hours or as directed by your physician.

Warnings

WARNINGS SECTION

Do not

  • Use this product for more than 7 days unless directed by a dentist or doctor
  • Exceed recommended dosage

Stop use and ask 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 develop

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 months or age and older: Dry affected area of oral mucosa. Apply the swab applicator every 3-4 hours or as directed by physician. Children under 6 months of age: Consult a dentist or Doctor

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature] in tight, light-resistant containers. Avoid exposure
to direct sunlight or heat.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-099-102020-01-31C16284748780-19d75b9d0-e422-f424-e053-dadaa90a57ceBenz Protect
54162-099-502020-01-31C16284748780-19d75b9d0-e422-f424-e053-dadaa90a57ceBenz Protect

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-099-10Benz Protect3 mL in 1 POUCHLIQUID32
54162-099-50Benz Protect150 mL in 1 BOXLIQUID1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-099BENZ PROTECT (BENZOIN RESIN) LIQUID [GERITREX LLC]2Legacy NDC, 2 package rows20171027_28e2879c-73c7-4715-b944-ebd0df3cec4f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-099-10EA - Each54162-099fcb10531-a2f8-4022-b4af-9878fdcf747312017-12-14

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54162-09954162-099-10, 54162-099-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIN RESINGK21SBA74RACTIB
ALCOHOL3K9958V90MIACT
ALOEV5VD430YW9IACT
LIQUIDAMBAR ORIENTALIS RESIN63V91G4W93IACT
TOLU BALSAMTD2LE91MBEIACT

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
5f075dba-c590-41bc-979d-5c69c93a8a1628e2879c-73c7-4715-b944-ebd0df3cec4f2017-10-27WarningsExact identifier
spl id: 5f075dba-c590-41bc-979d-5c69c93a8a16
spl set id: 28e2879c-73c7-4715-b944-ebd0df3cec4f

Reported adverse events (FAERS/openFDA)#

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