Label: GELATO TOPICAL ANESTHETIC- benzocaine spray, metered
- NDC Code(s): 68400-323-35
- Packager: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 11, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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.
Flammable. Do not use near fire or flame. Avoid smoking during use.
Do not use
- for teething
- in children under 2 years of age
- Keep out of reach of children.
- Directions
- Other information
- Inactive Ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GELATO TOPICAL ANESTHETIC
benzocaine spray, meteredProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68400-323 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 11.4 g in 57 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) ALCOHOL (UNII: 3K9958V90M) ISOBUTANE (UNII: BXR49TP611) PROPANE (UNII: T75W9911L6) Product Characteristics Color white (Clear) Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68400-323-35 57 g in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 09/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 07/29/2013 Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301) Establishment Name Address ID/FEI Business Operations Keystone Industries 014769301 manufacture(68400-323) , label(68400-323)