Gelato Topical Anesthetic description, usages, side effects, indications, overdosage, supplying and lots more!

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Gelato Topical Anesthetic

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


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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)

Gelato Topical Anesthetic

Gelato Topical Anesthetic

Gelato Topical Anesthetic

Benzocaine SPRAY, METERED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68400-323
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 11.4 g

Inactive Ingredients

Ingredient Name Strength
polyethylene glycol 400
saccharin sodium

Product Characteristics

Color
white (Clear)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68400-323-35 57 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2013-07-29


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Be sure to consult your doctor before taking any medication!
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