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GPS Topical Anesthetic by Group Practice Solutions, Inc.

Dosage form: gel
Ingredients: BENZOCAINE 200mg in 1g
Labeler: Group Practice Solutions, Inc.
NDC Code: 69004-003

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.

Active Ingredient 

Benzocaine 200mg (in each g)

Purpose

Oral Anesthetic

Use

For oral mucosa use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Warnings

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 immediate medical attention if you or a child in your care develops:

  • pale, gray or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use

  • for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
  • for teething
  • in children under 2 years of age

When using this product Avoid contact with eyes. If contact occurs, flush with water.

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a physician before use.

​Keep out of reach of children.

Directions
  • Apply only amount needed to the oral mucosa to prevent or relieve pain.
  • children under 2 years of age: do not use

Other Information

Store at 59° - 86°F (15°-30°C). Protect from freezing.

Inactive Ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Questions or comments?

631-532-2720

GPS TOPICAL ANESTHETIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69004-003
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 
POLYETHYLENE GLYCOL 400 
SACCHARIN SODIUM 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
FD&C RED NO. 3 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
FD&C GREEN NO. 3 
D&C RED NO. 28 
D&C GREEN NO. 5 
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69004-003-3030 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/2013
Labeler - Group Practice Solutions, Inc. (968188644)

 
Group Practice Solutions, Inc.

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Medically reviewed on Dec 31, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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