FDA Label for Anesthetic

View Indications, Usage & Precautions

Anesthetic Product Label

The following document was submitted to the FDA by the labeler of this product Moore Medical Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



First Aid

Drug Facts


Active Ingredient (In Each Gram)



Benzocaine 20.0% (w/w)


Purposes



Oral anesthetic


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



For oral use only


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 due to the possibility of anaphylactic shock.


When Using This Product



Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.


Keep Out Of Reach Of Children



If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.


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.
  • consult a dentist or doctor for use on children under 2 years of age
  • children under 12 years of age should be supervised in the use of this product

Other Information



  • Do not use if packet is torn, cut, or opened
  • Store at room temperature, 59° to 86°F (15° to 30°C)
  • Avoid contact with eyes

Inactive Ingredients



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


Questions Or Comments?



Call 800.234.1464


Principal Display Panel – 144 Count Box



mooremedical
Supporting Health & Care

Reorder No. 82474
UPN# 0-0607415-82474-2

MooreBrand
Orasol Gel 20%
75 Packets
Each Packet Net. Wt. 0.75gm

Temporary relief of minor pain
and sore mouth.

To Reorder:
Call: 1-800-234-1464
Fax: 1-800-944-6667
Online:
www.mooremedical.com


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