Drug Information

Product NDC: 75742-006

Proprietary Name: H2One

Non Proprietary Name: Ethyl Alcohol

Active Ingredient(s):
  • 75 mL/100mL ALCOHOL

Administration Route(s): TOPICAL

Dosage Form(s): GEL

Labeler Information

Labeler Name: Zhejiang Guoyao Jingyue Aerosol Co., Ltd.
Product Type: HUMAN OTC DRUG
FDA Application Number: part333A
Start Marketing Date:7/6/2020

Package Information

No. Package Code Package Description Billing Unit
175742-006-01237 mL in 1 BOTTLE, PUMP (75742-006-01)
275742-006-02375 mL in 1 BOTTLE, PUMP (75742-006-02)
375742-006-03250 mL in 1 BOTTLE, PUMP (75742-006-03)
475742-006-04500 mL in 1 BOTTLE, PUMP (75742-006-04)
575742-006-051000 mL in 1 BOTTLE, PUMP (75742-006-05)

NDC Record

Field Name Field Value Definition
PRODUCT NDC75742-006The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEH2OneThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEEthyl AlcoholThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEGELThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/6/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERpart333AThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEZhejiang Guoyao Jingyue Aerosol Co., Ltd.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALCOHOLAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

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This page was last updated on: 2/1/2023