Label: TOPICAL ANESTHETIC BUBBLE GUM- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50227-2114-1 - Packager: Patterson Dental Supply Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 6, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- USUAL DOSAGE
- INDICATIONS & USAGE
- WARNING
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label
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INGREDIENTS AND APPEARANCE
TOPICAL ANESTHETIC BUBBLE GUM
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50227-2114 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 220 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 400 (UNII: B697894SGQ) Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY) Polyethylene Glycol 3350 (UNII: G2M7P15E5P) Water (UNII: 059QF0KO0R) Product Characteristics Color PINK Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50227-2114-1 29.6 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 02/19/1963 Labeler - Patterson Dental Supply Inc (171843584)