NDC 80643-0002 Zeroq

Potassium Carbonate

NDC Product Code 80643-0002

NDC 80643-0002-1

Package Description: 500 mL in 1 BOTTLE, SPRAY

NDC Product Information

Zeroq with NDC 80643-0002 is a a human over the counter drug product labeled by Jisang Co., Ltd.. The generic name of Zeroq is potassium carbonate. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Jisang Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates 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.

Zeroq Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • POTASSIUM CARBONATE .5 g/500mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Jisang Co., Ltd.
Labeler Code: 80643
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product 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.

Start Marketing Date: 09-21-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Zeroq Product Label Images

Zeroq Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Potassium carbonate

Inactive Ingredient

E-polylysine, dextrin, 1,2-propanediol, citric acid, tea catechin, hydroxypropylmethyl cellulose, water

Otc - Purpose

Sanitizer to help decrease bacteria on skin

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Spray on skin as needed

Warnings

For external use only.When using this productAvoid contact with eyes. Discontinue use if signs of irritation or rashes appear.Keep out of reach of children.Store at room temperature.

Dosage & Administration

For external use only

* Please review the disclaimer below.