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#
Contacts and useful links#
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)
Products#
Every source-derived product name is available through these pages.
- Benzocaine
- Orajel Severe Toothache
- FD&C YELLOW NO. 5
- ALCOHOL
- SACCHARIN SODIUM
- FD&C RED NO. 40
- WATER
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-767 | 10237-767-45 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
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 |
|---|---|---|---|---|---|---|
| ac3d1f16-0c42-1a71-e053-2a95a90a101f | 4bcd575f-d77a-10d8-e054-00144ff88e88 | 2020-08-06 | Warnings | ac3d1f16-0c42-1a71-e053-2a95a90a101f 4bcd575f-d77a-10d8-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
