Orajel Instant Pain Relief

Manufacturer
Church Dwight Co., Inc.
Effective date
2017-04-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 01:16:57

Label at a glance#

ProductOrajel Instant Pain Relief Severe
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE, MENTHOL
Label structure12 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Menthol 0.25%

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Oral Pain reliever

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain due to toothaches
  • to help protect against infection in minor oral irritation

Warnings

WARNINGS SECTION

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

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 - ASK DOCTOR 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 - cut open tip of tube on score mark

  • Adults and children 2 years of age and over - Apply a samll amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as 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 physicaian or healthcare provider

Other information

OTHER SAFETY INFORMATION

  • do not use if tube tip is cut prior to opening
  • this preparation is inteded for use in cases of toothache, only as a temporary expedient until a physician can be consulted
  • do not use continuously
  • Orajel Severe Pain Formula will stay in place for extended duration of relief
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1

ORAL PAIN

Reliever for

Toothache

Now with 3X MORE

Active Ingredients vs. Store Brand

ORAJEL™

Instant Pain Relief

SEVERE

Toothache & Gum Relief Plus

Triple Medicated

20% Benzocaine to Relieve Oral Pain

Antiseptic to Help Prevent Infection

Menthol to Soothe

Oral Pain Reliever NET WT 0.33 OZ (9.4g)

Long-Lasting Cream

OJFC-32501-06

OJFC-32501-06.jpgOJFC-32501-06.jpg

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-74710237-747-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
27e73fcf-a59c-2f08-e063-6394a90a98704ce932f7-46fd-2caf-e054-00144ff88e882024-11-27WarningsExact identifier
spl set id: 4ce932f7-46fd-2caf-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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