NDC 72663-874 Wound Healer

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

NDC Product Code 72663-874

NDC 72663-874-64

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

NDC Product Information

Wound Healer with NDC 72663-874 is a a human over the counter drug product labeled by Welly Health Pbc. The generic name of Wound Healer is bacitracin zinc, neomycin sulfate, polymyxin b sulfate. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1359363.

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.

Wound Healer 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.


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.

  • ROYAL JELLY (UNII: L497I37F0C)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • COCOA BUTTER (UNII: 512OYT1CRR)

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: Welly Health Pbc
Labeler Code: 72663
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: 10-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Wound Healer Product Label Images

Wound Healer 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 Bacitracin)Neomycin Sulfate (3.5 mg Neomycin)Polymyxin B Sulfate (Polymyxin B 10,000 units)

Purpose

First aid antibiotic

Use

First aid to help prevent infection in minor: • cuts • scrapes • burns

Warnings

For external use only.Do not use: • in the eyes • over large areas of the body • if you are allergic to any of the ingredients.Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns.Stop use and ask a doctor if • you need to use longer than 1 week• condition persists or gets worse• symptoms persist for more than 1 week, or clear up and reoccur • rash or other allergic reaction develops.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.• Do not use if pregnant or breastfeeding

Directions

Adults and children 2 years and older:• clean affected area • apply a small amount (equal to the surface area of tip of finger) on area 1 to 3 times daily • may be covered with a sterile bandage.Children under 2 years: ask a doctor.

Other Information

Store at a controlled room temperature 68°– 77°F (20°– 25°C)

Inactive Ingredients

Apis Mellifera (Beeswax), Fractionated Coconut Oil, Glyceryl Stearate, Octyldodecanol, PEG-100 Stearate, Theobroma Cocoa (Cocoa Butter)

* Please review the disclaimer below.