Label: TOPICAL ANESTHETIC RASPBERRY- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 67239-0208-1 - Packager: Safco Dental Supply Co.
- 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 December 17, 2017
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- ACTIVE INGREDIENT
- USUAL DOSAGE
- WARNING
- HOW SUPPLIED
- INDICATIONS & USAGE
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Jar Label
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INGREDIENTS AND APPEARANCE
TOPICAL ANESTHETIC RASPBERRY
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67239-0208 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 200 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 400 (UNII: B697894SGQ) Saccharin Sodium (UNII: SB8ZUX40TY) Polyethylene Glycol 3350 (UNII: G2M7P15E5P) Water (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 28 (UNII: 767IP0Y5NH) Product Characteristics Color purple Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67239-0208-1 34 g in 1 JAR; Type 0: Not a Combination Product 08/06/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 08/06/2012 Labeler - Safco Dental Supply Co. (020417380) Registrant - Safco Dental Supply Co. (020417380)