Orajel Instant Pain Relief For All Mouth Sores

Manufacturer
Swabplus, L.P.
Effective date
2021-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:44:46

Label at a glance#

ProductOrajel Instant Pain Relief For All Mouth Sores
Active ingredientBENZOCAINE
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral Pain Reliever

Use

INDICATIONS & USAGE SECTION

Use for the temporary relief of pain associated with

  • canker sores
  • cold sores
  • fever blisters
  • minor irritation or injury of the mouth and gums.

Warnings

WARNINGS SECTION

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

DO NOT USE

OTC - DO NOT USE SECTION

Do not use

  • more than directed
  • for more than 7 days unless directed by a physician or healthcare provider

ASK DOCTOR

OTC - ASK DOCTOR/PHARMACIST 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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION SECTION

Directions -

Adults and children 2 years of age and over -

  • Hold swab with solid white tip down
  • Bend and snap open swab tip with the colored rings
  • Apply 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
  • Discard swab after application

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

OTHER SAFETY INFORMATION

  • do not use if label seal is broken prior to purchase or if the colored rings on tip are not blue
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
  • do not use continuously

Inactive Ingredients

INACTIVE INGREDIENT SECTION

flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5

Questions or Comments?

DESCRIPTION SECTION

call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at WWW.ORAJEL.COM

Orajel Instant Pain Relief For All Mouth Sores

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 Pharmacist Recommended

Brand for Adult Oral Pain

medicated swabs

Orajel

Instant Pain Relief

FOR ALL MOUTH SORES

MAXIMUM STRENGTH

Canker Sores Cold Sores Gum Irritation Cheek Bites Irritation from Dentures or Braces

12 UNIT DOSE SWABS NET 0.06 FL OZ (1.8 ML) TOTAL

BENZOCAINE 20% ORAL PAIN RELIEVER

Mouthsore LabelMouthsore Label

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
65734-50365734-503-12
10237-755

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
c28d37ef-bad0-cb2c-e053-2a95a90a87d9c28d37ef-bad1-cb2c-e053-2a95a90a87d92021-05-14WarningsExact identifier
spl id: c28d37ef-bad0-cb2c-e053-2a95a90a87d9
spl set id: c28d37ef-bad1-cb2c-e053-2a95a90a87d9

Reported adverse events (FAERS/openFDA)#

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