NDC 0113-0134 Benzethonium Chloride Plus Dyclonine Hydrochloride

Liquid Bandage

NDC Product Code 0113-0134

NDC CODE: 0113-0134

Proprietary Name: Benzethonium Chloride Plus Dyclonine Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Liquid Bandage What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 0113 - L. Perrigo Company
    • 0113-0134 - Benzethonium Chloride Plus Dyclonine Hydrochloride

NDC 0113-0134-03

Package Description: 9 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Benzethonium Chloride Plus Dyclonine Hydrochloride with NDC 0113-0134 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Benzethonium Chloride Plus Dyclonine Hydrochloride is liquid bandage. The product's dosage form is liquid and is administered via topical form.

Labeler Name: L. Perrigo Company

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.

Benzethonium Chloride Plus Dyclonine Hydrochloride 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 .2 mg/9mL
  • DYCLONINE HYDROCHLORIDE .75 mg/9mL

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.

  • ACETONE (UNII: 1364PS73AF)
  • AMYL ACETATE (UNII: 92Q24NH7AS)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • ETHYL ACETATE (UNII: 76845O8NMZ)
  • PYROXYLIN (UNII: KYR8BR2X6O)
  • ALCOHOL (UNII: 3K9958V90M)

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: L. Perrigo Company
Labeler Code: 0113
FDA Application Number: part333A 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: 12-20-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-20-2020 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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’.

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Benzethonium Chloride Plus Dyclonine Hydrochloride Product Label Images

Benzethonium Chloride Plus Dyclonine Hydrochloride 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 Ingredients

Benzethonium chloride 0.2%Dyclonine hydrochloride 0.75%

Purpose

First aid antisepticTopical analgesic

Uses

  • First aid to prevent bacteria contamination in minor cuts and scrapes

Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame.

Do Not Use

  • In the eyesover large areas of the bodylonger than 1 week unless directed by a doctoron infected areas or wounds that are drainingwith other first aid products such as lotions and creamsover sutureson mucous membranes

Ask A Doctor Before Use If You Have

  • Deep puncture woundsdeep cutsanimal bitesserious bleedingdiabetespoor circulationserious burns

When Using This Product

  • Do not sotre at temperaure above 120oFIntentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop Use And Ask A Doctor If

  • Conditions persists or gets worseinfection occurs

Keep Out Of Reach Of Children.

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

Directions

  • Clean affected areaapply a small amount on the area 1-3 times dailylet drya second coating may be applied for extra protectionto remove, apply more Liquid Bandage and quickly wipe offfinger nail polish remover may dissolve Liquid Bandage

Other Information

  • Cap bottle tightlystore at room temperature away from heatmay temporarily sting upon applicationdo not allow to come in contact with floors, countertops, or other finished surfaces - will stain

Inactive Ingredients

Acetone, amyl acetate, castor oil, ethyl acetate, nitrocellulose, SD slcohol 40

Questions

Call 1-866-964-0939

* Please review the disclaimer below.