NDC 50804-076 Goodsense Antibiotic Plus Pain Relief

Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride

NDC Product Code 50804-076

NDC CODE: 50804-076

Proprietary Name: Goodsense Antibiotic Plus 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: Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride 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

  • 50804 - Geiss, Destin & Dunn, Inc.

NDC 50804-076-01

Package Description: 1 TUBE in 1 CARTON > 14.2 g in 1 TUBE

NDC Product Information

Goodsense Antibiotic Plus Pain Relief with NDC 50804-076 is a a human over the counter drug product labeled by Geiss, Destin & Dunn, Inc.. The generic name of Goodsense Antibiotic Plus Pain Relief is neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1359360.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Goodsense Antibiotic Plus 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.


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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • 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: Geiss, Destin & Dunn, Inc.
Labeler Code: 50804
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: 03-21-2012 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 - 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.

Goodsense Antibiotic Plus Pain Relief Product Label Images

Goodsense Antibiotic Plus 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

Other

Drug Facts

Distributed by Geiss, Destin & Dunn, Inc Peachtree City, GA 30269

Otc - Purpose

Active ingredients (in each gram)PurposeNeomycin sulfate 3.5 mgFirst aid antibioticPolymyxin B sulfate 10,000 unitsFirst aid antibioticPramoxine hydrochloride 10 mgExternal analgesic

Uses

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

Warnings

For external use only.Not for prolonged use.

Do Not Use

  • In the eyes, nose, or over large areas of the bodyif you are allergic to any of the ingredientslonger than 1 week unless directed by a doctor

Ask A Doctor Before Use If You Have

  • Deep or puncture woundsanimal bitesserious burns

Stop Use And Ask A Doctor If

  • Condition persists for more than 7 days, gets worse, or clears up and occurs again within a few daysa rash or other allergic reaction developsredness, irritation, swelling, or pain persists or increases

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

  • Adults and children 2 years of age and 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 dailythe affected area may be covered with a sterile bandageChildren under 2 years of age: ask a doctor

Other Information

  • Store at 15 to 30°C (59 to 86°F)contents filled by weight, not volumeTamper Evident: DO NOT USE IF FLAPS ON CARTON ARE NOT SEALED OR MISSING

Inactive Ingredients

Cetearyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, purified water

* Please review the disclaimer below.