NDC 69968-0518 Neosporin Plus Burn Relief

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride

NDC Product Code 69968-0518

NDC Code: 69968-0518

Proprietary Name: Neosporin Plus Burn Relief Additional informationCallout TooltipWhat 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, And Pramoxine Hydrochloride Additional informationCallout TooltipWhat 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.


Code Structure
  • 69968 - Johnson & Johnson Consumer Inc.
    • 69968-0518 - Neosporin Plus Burn Relief

NDC 69968-0518-1

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

NDC Product Information

Neosporin Plus Burn Relief with NDC 69968-0518 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Neosporin Plus Burn Relief is bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

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 Additional informationCallout TooltipWhat 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.


Neosporin Plus Burn Relief Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

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

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Johnson & Johnson Consumer Inc.
Labeler Code: 69968
FDA Application Number: part333B Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Neosporin Plus Burn Relief Product Label Images

Neosporin Plus Burn 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:JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

Otc - Purpose

Active ingredients (in each gram)PurposeBacitracin Zinc (500 units)First aid antibioticNeomycin Sulfate (3.5 mg)First aid antibioticPolymyxin B Sulfate (10,000 units)First aid antibioticPramoxine HCl (10 mg)External analgesic

Uses

  • First aid to help prevent infection and for the temporary relief of pain 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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Centre right away.

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 dailymay be covered with a sterile bandagechildren under 2 years of age: ask a doctor

Other Information

  • Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

Petrolatum

Questions?

Call 800-223-0182 or outside the US 215-273-8755 (collect)

* Please review the disclaimer below.

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