NDC 80070-220 Anbesol Maximum Strength

Benzocaine

NDC Product Code 80070-220

NDC 80070-220-33

Package Description: 1 TUBE in 1 BLISTER PACK > 9 g in 1 TUBE

NDC Product Information

Anbesol Maximum Strength with NDC 80070-220 is a a human over the counter drug product labeled by Foundation Consumer Brands. The generic name of Anbesol Maximum Strength is benzocaine. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1052633 and 238910.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Anbesol Maximum Strength 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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SACCHARIN (UNII: FST467XS7D)

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: Foundation Consumer Brands
Labeler Code: 80070
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: 09-15-2021 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.

Anbesol Maximum Strength Product Label Images

Anbesol Maximum Strength 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: Foundation Consumer Brands, LLCPittsburgh, PA 15212

Active Ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Uses

  • Temporarily relieves pain associated with the following mouth and gum irritations:toothachesore gumscanker soresbracesminor dental proceduresdentures

Methemoglobinemia Warning

  • Use of this product may cause methemoglobinemia, a rare but 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 develops:pale, gray, or blue colored skin (cyanosis)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue 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 other "caine" anesthetics.

Do Not Use

  • For teethingin children under 2 years of age

When Using This Product

  • Avoid contact with the eyesdo not exceed recommended dosagedo not use for more than 7 days unless directed by a doctor/dentist

Stop Use And Ask A Doctor If

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • To open tube, cut tip of the tube on score mark with scissors adults and children 2 years of age and overapply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentistchildren under 12 years of ageadult supervision should be given in the use of this productchildren under 2 years of agedo not usefor denture irritation:apply thin layer to the affected areado not reinsert dental work until irritation/pain is relievedrinse mouth well before reinserting

Other Information

  • Store at 20-25°C (68-77°F)do not refrigerate

Inactive Ingredients

Benzyl alcohol, carbomer 934P, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin

* Please review the disclaimer below.