NDC 53329-093 Curad Germ Shield

Benzethonium Chloride

NDC Product Code 53329-093

NDC 53329-093-08

Package Description: 237 mL in 1 BOTTLE, SPRAY

NDC Product Information

Curad Germ Shield with NDC 53329-093 is a a human over the counter drug product labeled by Medline Industries, Inc.. The generic name of Curad Germ Shield is benzethonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Medline Industries, Inc.

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.

Curad Germ Shield 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.

  • BENZETHONIUM CHLORIDE .1 mg/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Medline Industries, Inc.
Labeler Code: 53329
FDA Application Number: part333E What is the FDA Application Number?
This 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 12-02-2019 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: 12-31-2020 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.

Curad Germ Shield Product Label Images

Curad Germ Shield 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

Active Ingredient

Benzethonium Chloride 0.1%

Purpose

First Aid Antiseptic

Uses

  • For first aid to help prevent infection inminor cutsscrapesburns

Warnings

For external use only.

Ask A Doctor Before Use If You Have

  • Deep or puncture woundsanimal bitesserious burns

When Using This Product

  • Do not use in or near the eyesdo not apply over large areas of the body or in large quantitiesdo not use longer than 1 week unless directed by a doctor

Stop Use And Ask Doctor If

  • Condition worsenssymptoms persist for more than 7 days, or clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean affected areaAdjust nozzle and spray a small amount of this product on the area 1 to 3 times dailyIf used as a wet compress, keep bandage wet with solutionIf covered with a sterile bandage, let dry first

Inactive Ingredients

Citric Acid, Cocamidopropyl Betaine, Disodium Phosphate, Phenoxyethanol, Water.

* Please review the disclaimer below.