NDC 30142-790 Antibiotic Plus Pain Relief

Neomycin, Polymyxin B, Pramoxine Hydrochloride

NDC Product Code 30142-790

NDC Code: 30142-790

Proprietary Name: 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, Polymyxin B, 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

  • 30142 - Kroger Company
    • 30142-790 - Antibiotic Plus Pain Relief

NDC 30142-790-58

Package Description: 1 TUBE in 1 CARTON > 14 g in 1 TUBE

NDC Product Information

Antibiotic Plus Pain Relief with NDC 30142-790 is a a human over the counter drug product labeled by Kroger Company. The generic name of Antibiotic Plus Pain Relief is neomycin, polymyxin b, pramoxine hydrochloride. The product's dosage form is cream and is administered via topical form.

Labeler Name: Kroger Company

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.

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.

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

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLOXAMER 188 (UNII: LQA7B6G8JG)
  • 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: Kroger Company
Labeler Code: 30142
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: 02-14-2019 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.

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

Active Ingredients (In Each Gram)

Neomycin sulfate equivalent to 3.5 mg of neomycin basePolymyxin B 10,000 units as polymyxin B sulfatePramoxine HCl 10 mg

Purpose

First aid antibioticExternal analgesic

Uses

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

Warnings

For external use only.

Do Not Use

  • •if you are allergic to any of the ingredients •in the eyes •over large areas of the body

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 occur again within a few days •rash or other allergic reaction develops

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • •adults and children 2 years of age or older: •clean the affected area •apply 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 daily •may be covered with a sterile bandage •children under 2 years of age: ask a doctor

Other Information

  • •store at 20o-25oC (68o-77oF)

Inactive Ingredients

Emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum

* Please review the disclaimer below.

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