NDC 43136-100 Avon Hexashield Triple Antibiotic With Pain Relief

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hcl

NDC Product Code 43136-100

NDC Code: 43136-100

Proprietary Name: Avon Hexashield Triple Antibiotic With Pain Relief 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: Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hcl 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

  • 43136 - Tai Guk Pharm. Co., Ltd.
    • 43136-100 - Avon Hexashield Triple Antibiotic With Pain Relief

NDC 43136-100-01

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC Product Information

Avon Hexashield Triple Antibiotic With Pain Relief with NDC 43136-100 is a a human over the counter drug product labeled by Tai Guk Pharm. Co., Ltd.. The generic name of Avon Hexashield Triple Antibiotic With Pain Relief is bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hcl. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Tai Guk Pharm. Co., Ltd.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Avon Hexashield Triple Antibiotic With Pain Relief 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.

  • POLYMYXIN B SULFATE 10000 [USP'U]/g
  • NEOMYCIN SULFATE 3.5 mg/g
  • BACITRACIN ZINC 500 [USP'U]/g
  • PRAMOXINE HYDROCHLORIDE 10 mg/g

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.

  • PETROLATUM (UNII: 4T6H12BN9U)

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.

Product Labeler Information

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

Labeler Name: Tai Guk Pharm. Co., Ltd.
Labeler Code: 43136
FDA Application Number: part333B 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 07-31-2019 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.

Information for Patients

Neomycin, Polymyxin, and Bacitracin Topical

Neomycin, Polymyxin, and Bacitracin Topical is pronounced as (nee oh mye' sin) (pol i mix' in) (bass i tray' sin)

Why is neomycin, polymyxin, and bacitracin topical medication prescribed?
Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and b...
[Read More]
Pramoxine

Pramoxine is pronounced as (pra mox' een)
Why is pramoxine medication prescribed?
Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation...
[Read More]

* Please review the disclaimer below.

Avon Hexashield Triple Antibiotic With Pain Relief 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 (In Each Gram)

Bacitracin Zinc 500 units
Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10 mg

Purpose

First aid antibiotic
External analgesic

Uses

  • First aid to help prevent infection and for temporary relief of pain or discomfort in minor:cutsscrapesburns

Warnings

For external use only.

Do Not Use

  • If you are allergic to any of the ingredientsin the eyesover large areas of the body

Ask A Doctor Before Use If You Have

  • Deep or puncture woundsanimal bitesserious burns

Stop Use And Ask A Doctor If

  • You need to use longer than 1 weekcondition persists or gets worsesymptoms persist for more than 1 week, or clear up and occur again within a few daysrash or other allergic reaction develops

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 2 years of age or older :
  • Clean the affected areaapply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times dailymay be covered with a sterile bandagechildren under 2 years of age: ask a doctor

Other Information

  • Store at room temperatureLot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredients

Ethanol, methylparaben, mineral oil, petrolatum, polyoxyl 40 stearate, propylparaben

* Please review the disclaimer below.

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