NDC 10565-003

Isopropyl Alcohol 50%

Isopropyl Alcohol 50%

Isopropyl Alcohol 50% is a Topical Solution in the Human Otc Drug category. It is labeled and distributed by Hydrox Laboratories. The primary component is Isopropyl Alcohol.

Product ID10565-003_168d3517-4679-4117-9827-63e9a9cd2b37
NDC10565-003
Product TypeHuman Otc Drug
Proprietary NameIsopropyl Alcohol 50%
Generic NameIsopropyl Alcohol 50%
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2019-06-11
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333A
Labeler NameHydrox Laboratories
Substance NameISOPROPYL ALCOHOL
Active Ingredient Strength50 mL/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10565-003-04

118 mL in 1 BOTTLE, PLASTIC (10565-003-04)
Marketing Start Date2019-06-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10565-003-04 [10565000304]

Isopropyl Alcohol 50% SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-11

NDC 10565-003-16 [10565000316]

Isopropyl Alcohol 50% SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-11

NDC 10565-003-08 [10565000308]

Isopropyl Alcohol 50% SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-11

NDC 10565-003-99 [10565000399]

Isopropyl Alcohol 50% SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-11

NDC 10565-003-32 [10565000332]

Isopropyl Alcohol 50% SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-11

Drug Details

Active Ingredients

IngredientStrength
ISOPROPYL ALCOHOL50 mL/100mL

OpenFDA Data

SPL SET ID:930bb3a3-5ca3-414c-b4fb-c71ee17fc746
Manufacturer
UNII
UPC Code
  • 0021599412838

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