Benzocaine, Menthol, Zinc Chloride
- Manufacturer
- Church & Dwight Co., Inc.
- Effective date
- 2019-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:50:50
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Benzocaine 20%
Menthol 0.5%
Zinc Chloride 0.15%
OTC - PURPOSE SECTION
Benzocaine - Oral pain reliever
Menthol - Oral pain reliever
Zinc Chloride - Oral astringent
INDICATIONS & USAGE SECTION
Use • for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums
WARNINGS SECTION
Warnings
• Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, 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 - 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 • cut open tip of tube on score mark
Adults and children 2 years of age and older - Apply a small amount of product to the affected area. 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 physician or healthcare provider
Other Information • do not use if tube tip is cut prior to opening • do not use continuously • Gel will stay in place for extended duration of relief
INACTIVE INGREDIENT SECTION
blue 1, cellulose gum. gelatin, methyl saliclate, mineral oil, pectin, petrolatum, polyethylen glycol, sodium saccharin
OTC - QUESTIONS SECTION
Question or comments call us at 800 952 5080 Monday through Friday 9-5 ET or visit our website at www orajel com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
#1
Oral Pain
Reliver Brand
For Toothache
New Formula!
3X More
Active Ingredients*
Orajel™
Instant Pain Relief
Severe
Toothache & Gum Relief Plus
Triple Medicated
20% Benzocaine to Relieve Oral Pain
Astringent to Relieve Gum Irritation
Menthol to Soothe Gums
Safety Sealed
Tube Tip
Fast Acting Gel
Oral Pain Reliver/Astringent NET WT 0.25 OZ (7.0g)
Products#
Every source-derived product name is available through these pages.
- Benzocaine, Menthol, Zinc Chloride
- Orajel Instant Pain Relief Severe
- CARBOXYMETHYLCELLULOSE SODIUM
- GELATIN
- SACCHARIN SODIUM
- FD&C BLUE NO. 1
- METHYL SALICYLATE
- MINERAL OIL
- PECTIN
- PETROLATUM
- POLYETHYLENE GLYCOL 1000
- BENZOCAINE
- ZINC CHLORIDE
- ZINC CATION
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-769 | 10237-769-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| GELATIN | 2G86QN327L | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PECTIN | 89NA02M4RX | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| ZINC CHLORIDE | 86Q357L16B | ACTIM |
| 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 |
|---|---|---|---|---|---|---|
| 99e867ff-94c4-63a3-e053-2995a90aabf2 | 4e1278e8-d181-05bf-e054-00144ff88e88 | 2019-12-17 | Warnings | 99e867ff-94c4-63a3-e053-2995a90aabf2 4e1278e8-d181-05bf-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
