NDC 0498-0021

Burn Water Soluble

Benzocaine, Benzethonium Chloride, Menthol

Burn Water Soluble is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Honeywell Safety Products Usa, Inc. The primary component is Benzocaine; Benzethonium Chloride; Menthol.

Product ID0498-0021_7a833ec5-66ff-7325-e053-2991aa0ada55
NDC0498-0021
Product TypeHuman Otc Drug
Proprietary NameBurn Water Soluble
Generic NameBenzocaine, Benzethonium Chloride, Menthol
Dosage FormSpray
Route of AdministrationTOPICAL
Marketing Start Date2018-11-12
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameHoneywell Safety Products USA, Inc
Substance NameBENZOCAINE; BENZETHONIUM CHLORIDE; MENTHOL
Active Ingredient Strength10 g/100g; g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0498-0021-40

85 g in 1 CAN (0498-0021-40)
Marketing Start Date2018-11-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0498-0021-40 [00498002140]

Burn Water Soluble SPRAY
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-12

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE10 g/100g

OpenFDA Data

SPL SET ID:6289fffc-69b8-4d4f-96b1-629578d84715
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1192516
  • UPC Code
  • 0669635200324
  • NDC Crossover Matching brand name "Burn Water Soluble" or generic name "Benzocaine, Benzethonium Chloride, Menthol"

    NDCBrand NameGeneric Name
    0498-0021Burn Water SolubleBenzocaine, Benzethonium chloride, Menthol
    0498-0020North BurnBenzocaine, Benzethonium chloride, Menthol

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.