Gelato topical anesthetic gel

Indications & usage section

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

Warnings section

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

Inactive ingredient section

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

  • FDC Blue 1
  • FDC Red 40
  • FDC Yellow 5 (tartrazine) as a color additive
  • FDC Yellow 6
  • Flavor
  • PEG 400
  • PEG 3350
  • Sodium Saccharin

Storage and handling section

  • Store at controlled room temperature 59-86 F (15-30 C)
  • Protect from freezing and heat

Ingredients and appearance - Product information

Gelato topical anesthetic gel- Benzocaine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68400-309
Route of Administration Dental

Active Ingredient/Active Moiety

Ingredient Name Strength
Benzocaine ( UNII: U3RSY48JW5)( Benzocaine - UNII: U3RSY48JW5 ) 6 gin 30 g

Inactive Ingredients

Ingredient Name Code
Polyethylene glycol 400 ( UNII: B697894SGQ)
Polyethylene glycol 3350 ( UNII: G2M7P15E5P)
Saccharin sodium ( UNII: SB8ZUX40TY)

Product Characteristics

Flavor PINEAPPLE (Pina Colada)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.( 078654194)

Establishment

Name ID/FEI Business Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. 078654194 manufacture( 68400-309), label( 68400-309)

Package label.principal display panel