ANESTHETIC- benzocaine liquid 
Moore Medical LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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, 15° to 30°C (59° to 86°F)
  • Avoid contact with eyes

Inactive Ingredients

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

Questions or Comments? 1-800-234-1464

PRINCIPAL DISPLAY PANEL – 144 count box

mooremedical
Supporting Health & Care

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

Temporary relief of minor
pain and sore mouth.

Reorder No. 82474

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

PRINCIPAL DISPLAY PANEL – 144 count box
ANESTHETIC 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55670-810
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzocaine (benzocaine) benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
polyethylene glycol 400 
polyethylene glycol 3350 
peppermint oil 
saccharin sodium dihydrate 
sorbic acid 
Packaging
#Item CodePackage Description
1NDC:55670-810-0175 in 1 BOX
10.75 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/12/2012
Labeler - Moore Medical LLC (051420107)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetecof America, Inc.874965262MANUFACTURE(55670-810)

Revised: 07/2012
 
Moore Medical LLC