Orajel Denture Pain Relief
- Manufacturer
- Church & Dwight Co., Inc.
- Effective date
- 2019-10-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:06:49
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Benzocaine 20%
Menthol 0.7%
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 • pain due to minor irritation of the mouth and gums caused by dentures • occasional minor irritation, pain, sore mouth.
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
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
cut open tube on score mark
Adults and children 2 years of age and over:
Apply a thin layer to the affected area. Do not reinsert dental work until irritation/pain is relieved. Rinse out well before reinserting. 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 sue if tube tip is cut prior to opening • this preparation is intended for use in cases of denture pain, only as a temporary expedent until a physician can be consulted • do not use continuously • Orajel Denture Pain Gel will stay in place for extended duration of relief
INACTIVE INGREDIENT SECTION
Inactive Ingredients blue 1, cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin, water
OTC - QUESTIONS SECTION
Questions or comments call us at 800 952 5080 Monday through Friday 9-5 or visit our website www orajel com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
#1
Oral Pain
Reliever Brand
For Adults
New Formula!
3x More
Active Ingredients*
Orajel
Instant Pain Relief
For Denture Pain
Soothes Gum Pain & Irritation
Triple Medicated
10% Benzocaine to Relieve Pain from Dentures
Astringent to Relieve Gum Irritation NEW
Menthol to Soothe Gums Irritated by Dentures
Refreshing Mint
Long-Lasting Gel
Oral Pain Reliever/Astringent NET WT 0.25 OZ (7.0g)
Products#
Every source-derived product name is available through these pages.
- Orajel Denture Pain Relief
- Benzocaine, Menthol, Zinc Chloride
- MINERAL OIL
- POTASSIUM SODIUM SACCHARATE
- CARBOXYMETHYLCELLULOSE SODIUM
- GELATIN, UNSPECIFIED
- PECTIN
- FD&C BLUE NO. 1
- PETROLATUM
- POLYETHYLENE GLYCOL, UNSPECIFIED
- BENZOCAINE
- MENTHOL
- ZINC CHLORIDE
- ZINC CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-778 | 10237-778-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINERAL OIL | T5L8T28FGP | IACT |
| POTASSIUM SODIUM SACCHARATE | 73U34YC90U | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| PECTIN | 89NA02M4RX | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
| ZINC CHLORIDE | 86Q357L16B | ACTIM |
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 |
|---|---|---|---|---|---|---|
| c4d301ce-8a39-5efb-e053-2995a90af995 | 552511b1-101c-7212-e054-00144ff88e88 | 2021-06-15 | Warnings | 552511b1-101c-7212-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
