NDC 75398-275

H2One Hand Sanitizer

Ethyl-alcohol

H2One Hand Sanitizer is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Samarian Products, Llc. The primary component is Alcohol.

Product ID75398-275_a354738e-769c-cade-e053-2a95a90a9075
NDC75398-275
Product TypeHuman Otc Drug
Proprietary NameH2One Hand Sanitizer
Generic NameEthyl-alcohol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2020-03-27
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333A
Labeler NameSamarian Products, LLC
Substance NameALCOHOL
Active Ingredient Strength75 mL/100mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 75398-275-10

1000 mL in 1 BOTTLE (75398-275-10)
Marketing Start Date2020-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75398-275-50 [75398027550]

H2One Hand Sanitizer GEL
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-27

NDC 75398-275-10 [75398027510]

H2One Hand Sanitizer GEL
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-27

Drug Details

Active Ingredients

IngredientStrength
ALCOHOL75 mL/100mL

OpenFDA Data

SPL SET ID:a3547747-2d12-e008-e053-2a95a90a214e
Manufacturer
UNII

NDC Crossover Matching brand name "H2One Hand Sanitizer" or generic name "Ethyl-alcohol"

NDCBrand NameGeneric Name
75398-275H2One Hand SanitizerETHYL-ALCOHOL
75398-580H2One Advanced Formula Hand SanitizerETHYL-ALCOHOL
75398-880Shaboink Alcohol WipeETHYL-ALCOHOL
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