Benzocaine

Manufacturer
Church & Dwight Co., Inc. | Accupac
Effective date
2019-07-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:17:39

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 or orthodontic appliances

WARNINGS

WARNINGS SECTION

Methemoglobinemia warning: Use of this product may cuse methemoglobinemia, a serious condition that must be treated promptly becasue it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray or blue colored skin (cyanosis) • headache • rapid heart rate • shortness or breath • dizziness or lightheadedness • fatigue or lack of engery

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.

OTC - DO NOT USE SECTION

Do not use • more than directed • for more than 7 days unless directed by a dentistor doctor •for teething •in children under 2 years of age

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

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 daily or as directed by a dentist or doctor

Children under 12 years of age

  • Ask a doctor before use. Should be supervised in the use of this product

Children under 2 years of age

  • Do not use

Other Information • do not use if safety seal on bottle cap is broken or missing prior to opening •

INACTIVE INGREDIENT SECTION

Inactive Ingredients alcohol (54.5% by volume), flavor, PEG-8, red 40, sodium saccarin, water, yellow 5

OTC - QUESTIONS SECTION

Questions or comment? Call us at 800 952 5080 M-F 9am-5pm or visit our website at www orajel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1

ORAL PAIN

RELIEVER BRAND

FOR TOOTHACHE

Fast-Acting Liquid!

Orajel

MEDICATED

FOR TOOTHACHE & GUM

Instant Pain Relief

•20% Benzocaine to Relieve Oral Pain

•Menthol to Soothe Gums

CANKER SORES • CHEEK BITES • DENTURE PAIN

IRRITATION FROM BRACES

ORAL PAIN RELIEVER

0.45 FL OZ (13.3mL)

OJFC-32945-07

OJFC-32945-07OJFC-32945-07

Products#

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DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-77710237-777-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
ac3c7f6a-41b6-2018-e053-2a95a90ab32e8effae88-ec66-fe9b-e053-2995a90aef982020-08-06WarningsExact identifier
spl set id: 8effae88-ec66-fe9b-e053-2995a90aef98

Reported adverse events (FAERS/openFDA)#

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