Mckesson Orasol Gel

Mckesson Orasol Gel
SPL v4
SPL
SPL Set ID cc8724f4-c482-5e7d-e053-2a95a90a608f
Route
TOPICAL
Published
Effective Date 2021-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol 3350 Polyethylene Glycol 400 Peppermint Oil Saccharin Sodium Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-04

Description

Drug Facts


Medication Information

Warnings and Precautions

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.

Indications and 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.

Dosage and 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

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
Section 50567-7

When using this product

  • avoid contact with eyes
Section 50570-1

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
Section 51727-6

Inactive ingredients

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

Section 51945-4

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

Section 53413-1

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

Section 55105-1

Purpose

Oral anesthetic

Section 55106-9

Active ingredient

Benzocaine 20% (w/w)

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Purpose

Oral anesthetic

Section 55106-9 (55106-9)

Active ingredient

Benzocaine 20% (w/w)

Section 60561-8 (60561-8)

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

Advanced Ingredient Data


Raw Label Data

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