NDC 0924-5607 First Aid Only Antibiotic Neomycin Sulfate

Antibiotic Ointment

NDC Product Code 0924-5607

NDC 0924-5607-01

Package Description: .9 g in 1 PACKET

NDC 0924-5607-02

Package Description: 10 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC 0924-5607-03

Package Description: 144 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC 0924-5607-05

Package Description: 20 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC Product Information

First Aid Only Antibiotic Neomycin Sulfate with NDC 0924-5607 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of First Aid Only Antibiotic Neomycin Sulfate is antibiotic ointment. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Acme United Corporation

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.

First Aid Only Antibiotic Neomycin Sulfate 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.

  • NEOMYCIN SULFATE 3.5 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: Acme United Corporation
Labeler Code: 0924
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: 12-18-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

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’.

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Information for Patients

Neomycin Topical

Neomycin Topical is pronounced as (nee oh mye' sin)

Why is neomycin topical medication prescribed?
Neomycin, an antibiotic, is used to prevent or treat skin infections caused by bacteria. It is not effective against fungal or viral infections.This medication is sometim...
[Read More]

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First Aid Only Antibiotic Neomycin Sulfate Product Label Images

First Aid Only Antibiotic Neomycin Sulfate 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 (Each Gram Contains)

Neomycin sulfate (equivalent to 3.5 mg Neomycin base)

Purpose

First aid antibiotic

Uses

  • First aid to help prevent infection inminor cutsscrapesburns

Warnings

For external use only

Do Not Use

  • In the eyes or apply 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

  • Puncture wounds, animal bites, or serious burns

Stop Use And Ask A Doctor If

  • The condition persists or gets worseA rash or other allergic reaction develops

Keep Out Of The Reach Of Children

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

Directions

  • 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 bandage

Other Information

  • Store at room temperature 59° to 77°F (15°to 25°C)

Inactive Ingredients

Petrolatum

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