NDC 70704-212

Burn Solution Cream

Tetracaine Cream

Burn Solution Cream is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Burn Solution Foundations. The primary component is Tetracaine.

Product ID70704-212_7bacc520-e975-ba84-e053-2a91aa0a0084
NDC70704-212
Product TypeHuman Otc Drug
Proprietary NameBurn Solution Cream
Generic NameTetracaine Cream
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2016-08-23
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameBurn Solution Foundations
Substance NameTETRACAINE
Active Ingredient Strength10 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70704-212-35

12 TUBE in 1 BOX (70704-212-35) > 10 mL in 1 TUBE (70704-212-34)
Marketing Start Date2016-08-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70704-212-35 [70704021235]

Burn Solution Cream CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-23

NDC 70704-212-34 [70704021234]

Burn Solution Cream CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-23

Drug Details

Active Ingredients

IngredientStrength
TETRACAINE10 mg/mL

OpenFDA Data

SPL SET ID:3a5cf648-cc76-620e-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313246

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