NDC 37945-212

Burn Cream

Tetracaine

Burn Cream is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Bio-medical & Pharmaceutical Manufacturing Corporation. The primary component is Tetracaine.

Product ID37945-212_3a477714-6ff4-62aa-e054-00144ff8d46c
NDC37945-212
Product TypeHuman Otc Drug
Proprietary NameBurn Cream
Generic NameTetracaine
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2016-08-19
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameBio-Medical & Pharmaceutical Manufacturing Corporation
Substance NameTETRACAINE
Active Ingredient Strength10 mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 37945-212-35

12 TUBE in 1 BOX (37945-212-35) > 10 mL in 1 TUBE (37945-212-34)
Marketing Start Date2016-08-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 37945-212-34 [37945021234]

Burn Cream CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-19

NDC 37945-212-35 [37945021235]

Burn Cream CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-19

Drug Details

Active Ingredients

IngredientStrength
TETRACAINE10 mg/mL

OpenFDA Data

SPL SET ID:3a477714-6ff3-62aa-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313246
  • NDC Crossover Matching brand name "Burn Cream" or generic name "Tetracaine"

    NDCBrand NameGeneric Name
    37945-212Burn Creamtetracaine
    69396-105Burn CreamBenzalkonium Chloride, Lidocaine HCI
    70372-729BLT 3TETRACAINE
    54723-004FranklyNumb 3Tetracaine
    67194-020Numfast Tetracaine GreenTETRACAINE
    71888-103TetracaineTetracaine
    67194-013Tetragel Punch Topical AnalgesicTETRACAINE

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