GELATO TOPICAL ANESTHETIC- benzocaine spray, metered 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc

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.

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Active Ingredient:

Benzocaine 20%

Purpose:

Oral Anesthetic

Uses:

For the temporary relief of occasional minor irritation and pain associated with:

  • canker sores
  • minor dental procedures

Keep out of reach of children.

Warnings:

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Discontinue 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 two hours after use.

Allergy Alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Flammable. Do not use near fire or flame. Avoid smoking during use.

Avoid spraying in eyes

Do not store above 120°F (49°C)

Store at room temperature

Dispose of in a manner consistent with local regulations

For Professional Use Only.

Dosage:

A single metered spray dispenses 50mg of Gelato Topical Anesthetic. Use only as directed by a dentist.

Inactive Ingredients:

Flavor, Polyethylene Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and propane)

BenzocaineSprayMint

BenzocaineSprayBox

GELATO TOPICAL ANESTHETIC 
benzocaine spray, metered
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68400-323
Route of AdministrationORAL, TOPICAL, DENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE11.4 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-323-3557 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/29/2013
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (078654194)
Establishment
NameAddressID/FEIBusiness Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc078654194manufacture(68400-323), label(68400-323)

Revised: 8/2013
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc