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#

ProductMcKesson Orasol Gel
Active ingredientBENZOCAINE
Label structure14 sections

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

McKessonMcKesson

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN4
238910benzocaine 0.2 MG/MG Oral GelSCD4
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-8247-4McKesson Orasol Gel0.75 g in 1 PACKETGEL0.754
68599-8247-4McKesson Orasol Gel75 in 1 BOXGEL754

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-824768599-8247-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
McKesson Orasol GelBENZOCAINE 20%McKesson Medical-Surgicalcc8724f4-c482-5e7d-e053-2a95a90a608f2025-09-09WarningsExact identifier
ndc (package): 68599-8247-4
ndc (product): 68599-8247
ndc11 (package): 68599824704
spl id: 3e5d7484-4608-9005-e063-6294a90a3307
spl set id: cc8724f4-c482-5e7d-e053-2a95a90a608f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.