Label: GELATO TOPICAL ANESTHETIC- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 68400-504-25 - Packager: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated November 19, 2013
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INGREDIENTS AND APPEARANCE
GELATO TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-504 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 2.4 g in 12 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 400 (UNII: B697894SGQ) Polyethylene Glycol 3350 (UNII: G2M7P15E5P) Saccharin Sodium (UNII: SB8ZUX40TY) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain FD&C YELLOW NO. 5 (UNII: I753WB2F1M) May contain FD&C YELLOW NO. 6 (UNII: H77VEI93A8) May contain FD&C RED NO. 3 (UNII: PN2ZH5LOQY) May contain FD&C RED NO. 40 (UNII: WZB9127XOA) May contain FD&C BLUE NO. 1 (UNII: H3R47K3TBD) May contain FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Product Characteristics Color yellow Score Shape Size Flavor PINEAPPLE (Pina Colada) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68400-504-25 12 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date export only 12/12/2012 Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (078654194) Registrant - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301) Establishment Name Address ID/FEI Business Operations Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. 078654194 manufacture(68400-504) , label(68400-504)
