MCKESSON ORASOL GEL- benzocaine 20% gel

McKesson Orasol Gel by

Drug Labeling and Warnings

McKesson Orasol Gel by is a Otc medication manufactured, distributed, or labeled by McKesson Medical-Surgical, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzocaine 20% (w/w)

PURPOSE

Purpose

Oral anesthetic

INDICATIONS & USAGE

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

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.

DO NOT USE

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

STOP USE

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

WHEN USING

When using this product

• avoid contact with eyes

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If accidentally swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

Inactive ingredients

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

QUESTIONS

Questions or comments? Call 1-800-777-4908

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

INGREDIENTS AND APPEARANCE

MCKESSON ORASOL GEL 
benzocaine 20% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-8247
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PEPPERMINT OIL (UNII: AV092KU4JH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-8247-4	75 in 1 BOX	10/04/2021
1		0.75 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	10/04/2021

Labeler - McKesson Medical-Surgical (023904428)

Registrant - Unifirst First Aid Corporation (832947092)