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#
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 or orthodontic appliances
WARNINGS
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
Products#
Every source-derived product name is available through these pages.
- Benzocaine
- Orajel Severe Toothache
- POLYETHYLENE GLYCOL, UNSPECIFIED
- FD&C YELLOW NO. 5
- ALCOHOL
- SACCHARIN SODIUM
- FD&C RED NO. 40
- WATER
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-777 | 10237-777-45 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| 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 |
|---|---|---|---|---|---|---|
| ac3c7f6a-41b6-2018-e053-2a95a90ab32e | 8effae88-ec66-fe9b-e053-2995a90aef98 | 2020-08-06 | Warnings | 8effae88-ec66-fe9b-e053-2995a90aef98 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
