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#
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients
Benzocaine 20%
Purpose
Oral Pain Reliever
Use
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
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
Do not use
- more than directed
- for more than 7 days unless directed by a physician or healthcare provider
ASK DOCTOR
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
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
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
- 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
flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5
Questions or Comments?
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
#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
Products#
Every source-derived product name is available through these pages.
- Orajel Instant Pain Relief For All Mouth Sores
- Benzocaine
- POLYETHYLENE GLYCOL 1000
- WATER
- METHYL SALICYLATE
- SACCHARIN SODIUM
- FD&C RED NO. 40
- FD&C YELLOW NO. 5
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65734-503 | 65734-503-12 |
| 10237-755 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| c28d37ef-bad0-cb2c-e053-2a95a90a87d9 | c28d37ef-bad1-cb2c-e053-2a95a90a87d9 | 2021-05-14 | Warnings | c28d37ef-bad0-cb2c-e053-2a95a90a87d9 c28d37ef-bad1-cb2c-e053-2a95a90a87d9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
