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 ID: 75398-275_a354738e-769c-cade-e053-2a95a90a9075
• NDC: 75398-275
• Product Type: Human Otc Drug
• Proprietary Name: H2One Hand Sanitizer
• Generic Name: Ethyl-alcohol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2020-03-27
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part333A
• Labeler Name: Samarian Products, LLC
• Substance Name: ALCOHOL
• Active Ingredient Strength: 75 mL/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 75398-275-10

1000 mL in 1 BOTTLE (75398-275-10)

• Marketing Start Date: 2020-03-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75398-275-50 [75398027550]

H2One Hand Sanitizer GEL

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-03-27

NDC 75398-275-10 [75398027510]

H2One Hand Sanitizer GEL

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-03-27

Drug Details

Active Ingredients

Ingredient	Strength
ALCOHOL	75 mL/100mL

OpenFDA Data

• SPL SET ID: a3547747-2d12-e008-e053-2a95a90a214e
• Manufacturer:
  • Samarian Products, LLC
• UNII:
  • 3K9958V90M

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

NDC	Brand Name	Generic Name
75398-275	H2One Hand Sanitizer	ETHYL-ALCOHOL
75398-580	H2One Advanced Formula Hand Sanitizer	ETHYL-ALCOHOL
75398-880	Shaboink Alcohol Wipe	ETHYL-ALCOHOL