Benzocaine

Manufacturer
Church & Dwight Co., Inc. | Accupac
Effective date
2020-08-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:19:02

Label at a glance#

ProductBenzocaine
Active ingredientBENZOCAINE, MENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Menthol 0.1%

OTC - PURPOSE SECTION

Oral Pain Reliever

INDICATIONS & USAGE SECTION

Use for the temporary relief of pain due to • canker sores • minor injury of the mouth and gum • minor irritation of the mouth and gums caused by dentures

WARNINGS SECTION

Warnings

Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

Flammable: keep away from fire or flame. Avoid smoking during application and until this product has been dried

OTC - DO NOT USE SECTION

Do not use • more than directed • for more than 7 days unless directed by a physician or healthcare provider

OTC - STOP USE SECTION

Stop use and ask a physician if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions • remove imprinted safety seal from bottle cap

Adults and children 2 years of age and over

Apply product with cotton swab or finger to the affected area. Use up to 4 times a day or ad directed by a physician or healthcare provider

Children under 12 years of age

Should be supervised in the use of this product

Children under 2 years of age

Ask a physician or healthcare provider

Other Information • do not use if imprinted bottle seal is broken or missing prior to opening • do not continuously

INACTIVE INGREDIENT SECTION

Inactive Ingredients alcohol (54.5% by volume), flavor, polyehtylene glycol, red 40, sodium saccarin, water, yellow 5

OTC - QUESTIONS SECTION

Questions or comment? Call us at 800 952 5080 Mon thru Fri 9-5 or visit our website at www orajel com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1

ORAL PAIN

RELIEVER BRAND

FOR TOOTHACHE

2X MORE

Active

Ingredients*

Orajel

Instant Pain Relief

SEVERE

Toothache & Gum Relief Plus

DOUBLE MEDICATED

20 % Benzocaine to Relieve Oral Pain

Menthol to Soothe Gums

FAST-ACTING

LIQUID

ORAL PAIN RELIEVER 0.45 FL OZ (13.3mL)

OJFC-32945-06.jpgOJFC-32945-06.jpg

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-76710237-767-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
ac3d1f16-0c42-1a71-e053-2a95a90a101f4bcd575f-d77a-10d8-e054-00144ff88e882020-08-06WarningsExact identifier
spl id: ac3d1f16-0c42-1a71-e053-2a95a90a101f
spl set id: 4bcd575f-d77a-10d8-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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