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

Gelato Topical Anesthetic

Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products 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 Ingredients ():

Benzocaine 200mg

Purpose:

Oral Anesthetic

Use:

For oral mucosal use. 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 healthcare 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 breast feeding, ask a health professional before 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.

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 #3, red #40, blue #1, green #3 as a color additive.

Gelato Topical Anesthetic

Benzocaine GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68400-356
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
yellow

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68400-356-30 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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