NDC 68400-478

Quala Topical Anesthetic Gel

Benzocaine

Quala Topical Anesthetic Gel is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.. The primary component is Benzocaine.

Product ID68400-478_d722bf24-ae86-54f6-e053-2995a90a1d35
NDC68400-478
Product TypeHuman Otc Drug
Proprietary NameQuala Topical Anesthetic Gel
Generic NameBenzocaine
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2022-02-03
Marketing CategoryOTC MONOGRAPH NOT FINAL /
Application Numberpart356
Labeler NameMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Substance NameBENZOCAINE
Active Ingredient Strength200 mg/g
Pharm ClassesAllergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68400-478-30

30 g in 1 JAR (68400-478-30)
Marketing Start Date2022-02-03
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Quala Topical Anesthetic Gel" or generic name "Benzocaine"

NDCBrand NameGeneric Name
43128-031Quala Topical Anesthetic GelQuala Topical Anesthetic Gel
43128-029Quala Topical Anesthetic GelQuala Topical Anesthetic Gel
43128-032Quala Topical Anesthetic GelQuala Topical Anesthetic Gel
43128-033Quala Topical Anesthetic GelQuala Topical Anesthetic Gel
43128-028Quala Topical Anesthetic GelQuala Topical Anesthetic Gel
43128-034Quala Topical Anesthetic GelQuala Topical Anesthetic Gel
0283-0220HurriCaineBenzocaine
0283-0293HurriCaineBenzocaine
0283-0520HurriCaineBenzocaine
0283-0569HurriCaineBenzocaine
0283-0679HurriCaineBenzocaine
0283-0871HurriCaineBENZOCAINE
0283-0886HurriCaineBenzocaine
0283-0914HurriCaineBenzocaine
0283-0920HurriCaineBenzocaine
0283-0998HurriCaineBenzocaine
0283-1016HurriCaineBENZOCAINE
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.