NDC 24286-1577 Bactimicina For Sore Throat

Benzocaine

NDC Product Code 24286-1577

NDC CODE: 24286-1577

Proprietary Name: Bactimicina For Sore Throat 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: Benzocaine 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.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: OVAL (C48345)
Size(s):
20 MM
Score: 1
Flavor(s):
ORANGE (C73406)

NDC Code Structure

  • 24286 - Dlc Laboratories, Inc.

NDC 24286-1577-1

Package Description: 3 BLISTER PACK in 1 BOX > 6 LOZENGE in 1 BLISTER PACK

NDC Product Information

Bactimicina For Sore Throat with NDC 24286-1577 is a a human over the counter drug product labeled by Dlc Laboratories, Inc.. The generic name of Bactimicina For Sore Throat is benzocaine. The product's dosage form is lozenge and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1110712 and 199071.

Dosage Form: Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.

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.

Bactimicina For Sore Throat 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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SUCROSE (UNII: C151H8M554)
  • HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • CORN SYRUP (UNII: 9G5L16BK6N)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dlc Laboratories, Inc.
Labeler Code: 24286
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 12-21-2021 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.

Bactimicina For Sore Throat Product Label Images

Bactimicina For Sore Throat 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 (In Each Lozenge)

Benzocaine 15 mg

Purpose

Oral anesthetic/Analgesic

Use

  • Temporarily relieve:occational minor irritation, pain, sore mouth and sore throat

Methemoglobinemia Warning:

  • Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care developes:pale, gray, or blue colored skin (cyanosis)shortness of breathheadachedizziness or lightheadednessrapid heart ratefatigue or lack of energy

Allergy Alert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or any other "caine" anesthetics. If skin reation occurs, stop use and seek medical help right away.

Sore Throat Warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • For teethingin children under 5 years of age

When Using This Product

  • Do not exceed recommended dosage

Stop Use And Ask A Doctor If

  • Sore mouth symptoms do not improve in 7 daysirritation, pain or redness persists or worsensswelling, rash or fever develops

If Pregnant Or Breast-Feeding

Ask a health professional before use

Keep Out Of Reach Of Children

In case of overdose, or if more than used for pain relief is accidentally swallowed, get medical help or contact a Poison COntrol Center immediately

Directions

  • Adults and children 5 years of age and older:Dissolve 1 lozenge slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist.children under 5 years of age: do not use.

Other Information

  • Protect from moisturestore at room temperaturecheck expiration date before using

Inactive Ingredients

Dextrose, FD&C yellow #6, FD&C red #40, corn syrup, hydrogenated cottonseed oil, natural and artificial flavor, propylene glycol, sucrose

Question

1-800-858-3889

Other

Distributed byDe La Cruz ProductsA Division of DLC Laboratories, Inc.Paramount, CA 90723 USA

Principle Display

Fast ActingTrusted since 1978New LookMaximum StrengthBactimicina ®Sore Throat Pain ReliefBenzocain Oral AnestheticOrange Flavor18 Lozenges

* Please review the disclaimer below.