NDC 53145-301 Anestenka

Benzocaine Liquid Topical

NDC Product Information

Anestenka with NDC 53145-301 is a human over the counter drug product labeled by Menper Distributors, Inc. The generic name of Anestenka is benzocaine. The product's dosage form is liquid and is administered via topical form.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Anestenka 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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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.

Pharmacologic Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.


Product Labeler Information

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

Labeler Name: Menper Distributors, Inc
Labeler Code: 53145
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: 01-01-2014 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: 12-31-2023 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.

Anestenka Product Label Images

Anestenka 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 Ingrediets(%)

Benzocaine 10%

Purpose

Oral Pain Reliever

Uses

For temporary relief of pain due to toothaches and sure gums.

Methemoglobinemia Warning:

  • Use of this product may cause methemoglobinemia, a seious condition that must be treated promtly because it reduces the amount of oxygen carried in blood. This can occurred even if you have used this product before. Stop used and seek immediate medical attention if you or a child in your care develops:pale, gray, or blue colored skin (cyanosis)headacherapid hear rate shortness of breathdizziness or lightheadedness fatigue or lack of energy

Allergy Alert:

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

Sore Throat Warning:

If sore throat is severe, persists for more that two days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persist or worsens, see your dentist dentist or doctor promptly.

Do Not Use:

  • More than directed for teething for more than 7 days unless told to do so by a dentist or doctor on child under 12 years of age unless told to do so by a dentist or doctor

When Using This Product:

  • Avoid contact with eyes do not exceed recomended dosagefever and nasal congestion are not symptoms of toothache or sore gums and may indicate the presence of infection. If these symptoms do not go away, advise your dentist or doctor.

Stop Use And Ask Dentist Or Doctor If :

  • Sore mouth symptoms do not get better in 7 days swelling, rash or fever developsirritation, pain, or redness do not go awayRedness or swelling is presented

If Pregnant Or Breast-Feeeding

Ask a health professional before use.

Keep Out Of Reach Of Children,

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

  • (For adults and children 12 years or older)wash handsRemove cap and cut off tip dispenser use your finger or cotton applicator (swab) to apply a small (pea-size) amount of Anestenka to the affected area Apply Anestenka to the affected area up to 4 times daily or as directed by the demtist or doctorFor children 12 years of age: Consult a dentist or doctor

Other Information:

Store at room temperature: 15-30° C (59-86° F)Tamper Evident Feature:Do not use if tip is cut prior to opening.Do not use for toothache as more than a temporary expedient until a dentidst can be contacted.

Inactive Ingredients:

Methylparaben, propylene glycol, propyparaben

* Please review the disclaimer below.