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Drug Facts
Mckesson Orasol Gel
FDA Label NDC 68599-8247
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson Medical-surgical for the product Mckesson Orasol Gel (NDC 68599-8247). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Benzocaine 20% (w/w)
Otc - 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.
Otc - 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
Otc - 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
Otc - When Using
When using this product
- avoid contact with eyes
Otc - 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
Otc - Questions
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
* Please review the disclaimer below.
