McKesson Orasol Gel
- Manufacturer
- McKesson Medical-Surgical | Unifirst First Aid Corporation
- Effective date
- 2025-09-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:13:19
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Benzocaine 20% (w/w)
OTC - PURPOSE SECTION
Purpose
Oral anesthetic
INDICATIONS & USAGE SECTION
Uses
For the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.
WARNINGS SECTION
Warnings
For oral use only.
Do not exceed recommended dosage.
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because 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 medical attention if you or a child in your care develops:
- pale, gray or blue colored skin (cyanosis)
- rapid heart rate
- dizziness or lightheadedness
- headache
- shortness of breath
- fatigue or lack of energy
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. If a skin reaction occurs, stop use and seek medical help right away.
OTC - DO NOT USE SECTION
Do not use
- for teething - any teething related indication will not be ab appropriate use of this product
- in children under 2 years of age
- for more than 7 days unless directed by a doctor
OTC - STOP USE SECTION
Stop use and ask a dentist or doctor if
- sore mouth does not improve in 7 days
- irritation, pain, or redness persists or worsens
- swelling, rash, fever or other allergic reaction develops
OTC - WHEN USING SECTION
When using this product
- avoid contact with eyes
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If accidentally swallowed get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
Adults and children (2 years and older):
Dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.
Children under 2 years:
Do not use
OTHER SAFETY INFORMATION
Other information
- do not use if packet is torn, cut or opened
- store at room temperature: 59° to 86°F (15° to 30°C)
- tamper evident sealed packets
INACTIVE INGREDIENT SECTION
Inactive ingredients
PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid
OTC - QUESTIONS SECTION
Questions or comments? Call 1-800-777-4908
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 68599-8247-4
McKesson
Orasol Gel
Individual Packets
Benzocaine 20% | Oral Anesthetic
Temporary relief of minor pain and sore mouth.
NET WT 0.75 g
75 Packs Per Box
Do Not Reuse
MFR # 82474
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68599-8247-4 | McKesson Orasol Gel | 0.75 g in 1 PACKET | GEL | 0.75 | 4 | |
| 68599-8247-4 | McKesson Orasol Gel | 75 in 1 BOX | GEL | 75 | 4 |
Products#
Every source-derived product name is available through these pages.
- McKesson Orasol Gel
- Benzocaine 20%
- POLYETHYLENE GLYCOL 3350
- POLYETHYLENE GLYCOL 400
- PEPPERMINT OIL
- SACCHARIN SODIUM
- BENZOCAINE
- SORBIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68599-8247 | 68599-8247-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| SORBIC ACID | X045WJ989B | 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 |
|---|---|---|---|---|---|---|
| McKesson Orasol Gel | BENZOCAINE 20% | McKesson Medical-Surgical | cc8724f4-c482-5e7d-e053-2a95a90a608f | 2025-09-09 | Warnings | 68599-8247-4 68599-8247 68599824704 3e5d7484-4608-9005-e063-6294a90a3307 cc8724f4-c482-5e7d-e053-2a95a90a608f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
