GELATO TOPICAL ANESTHETIC- benzocaine gel 
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 Ingredients 

Benzocaine 200mg (in each g)

Purpose:

Oral Anesthetic

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Warnings:

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use

  • for more than 7 days unless directed by a physician. 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 physician promptly.
  • for teething
  • in children under 2 years of age

When using this product Avoid contact with eyes. If contact occurs, flush with water.

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a physician before use. 

Directions

  • Apply only amount needed to the oral mucosa to prevent or relieve pain.
  • children under 2 years of age: do not use

Keep out of reach of children.

Other Information:

Store at 59°-86°F (15°-30°C). Protect from freezing.

Inactive Ingredients:

Flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow#5 (tartrazine), yellow #6, as a color additive.

Questions or comments?

1-800-333-3131 or

keystoneindustries.com

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GELATO TOPICAL ANESTHETIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68400-350
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorBANANAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-350-3030 g in 1 JAR; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/2013
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)
Establishment
NameAddressID/FEIBusiness Operations
Keystone Industries014769301manufacture(68400-350) , label(68400-350)

Revised: 1/2022
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc