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.
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

Uses

DIRECTIONS: For oral mucosa. Use only as directed by a dentist.

CAUTION: Keep out of reach of children. For professional use only.

Each gram of 20 percent benzocaine gel contains 200mg of benzocaine in a water soluble base of:

  • FDC Red 40
  • Flavor
  • PEG 400
  • PEG 3350
  • Sodium Saccharin
  • Store at controlled room temperature 59-86 F (15-30 C)
  • Protect from freezing and heat

Gelato Topical Anesthetic

Benzocaine GEL

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:68400-305
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 6 g

Inactive Ingredients

Ingredient Name Strength
polyethylene glycol 400
POLYETHYLENE GLYCOL 3350
saccharin sodium

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68400-305-30 30 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-12-12


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