GPS Topical Anesthetic description, usages, side effects, indications, overdosage, supplying and lots more!

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GPS Topical Anesthetic

Group Practice Solutions, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each gram)

Benzocaine 200mg

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

​Allergy alert: ​Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics. 

​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; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

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

​Stop use and consult a health care practitioner ​if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.

​Do not exceed recommended dosage. ​If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately. 

​If pregnant or breastfeeding, ​ask a health professional before use.

​Keep out of reach of children.

Directions

Apply only amount needed to the oral mucosa to prevent or relieve pain.

Other Information

Store at 59° - 86°F (15°-30°C).

Protect from freezing.

Inactive Ingredients

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

Questions or comments?

631-532-2720

GPS Topical Anesthetic

Benzocaine GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:69004-005
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 200 mg
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

Inactive Ingredients

Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
polyethylene glycol 400
saccharin sodium

Product Characteristics

Color
red

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69004-005-30 30 in 1 JAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2013-07-01


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