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Gelato Topical Anesthetic by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc

Dosage form: spray, metered
Ingredients: BENZOCAINE 11.4g in 57g
Labeler: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
NDC Code: 68400-323

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.

Active Ingredient:

Benzocaine 20%

Purpose:

Oral Anesthetic

Uses:
  • For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.
  • For Professional Use Only.

Warnings

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

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

Stop use and ask a doctor if you experience any of the following symptoms:

  • weakness
  • confusion
  • headache
  • difficulty breathing
  • 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.

Keep out of reach of children.

If more than used for pain is accidentally swallowed, get medical help or contact a poison Control Center immediately. Avoid spraying in eyes

Dosage

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

Other information

Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

Inactive Ingredients

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

Questions or comments?

1-800-333-3131

GELATO TOPICAL ANESTHETIC 
benzocaine spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68400-323
Route of AdministrationDENTALDEA 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
Colorwhite (Clear) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
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 (014769301)
Establishment
NameAddressID/FEIOperations
Keystone Industries014769301manufacture(68400-323), label(68400-323)

 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc

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Medically reviewed on Aug 22, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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