Gelato Topical Anesthetic Spray, Metered
FDA Label NDC 68400-323

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc for the product Gelato Topical Anesthetic (NDC 68400-323). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient:, purpose:, uses:, warnings, keep out of reach of children., dosage, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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