NDC 42961-810 Dental Relief

Benzocaine

NDC Product Code 42961-810

NDC 42961-810-03

Package Description: 10 PACKET in 1 BAG > .5 g in 1 PACKET (42961-810-02)

NDC 42961-810-04

Package Description: 500 PACKET in 1 BOX > .5 g in 1 PACKET (42961-810-02)

NDC Product Information

Dental Relief with NDC 42961-810 is a a human over the counter drug product labeled by Cintas Corporation. The generic name of Dental Relief is benzocaine. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Cintas Corporation

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.

Dental 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.

  • BENZOCAINE 200 mg/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.

  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBIC ACID (UNII: X045WJ989B)

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: Cintas Corporation
Labeler Code: 42961
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: 04-08-2021 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.

Dental 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 FactsDental Relief

Active Ingredients

Benzocaine 20% (w/w)

Purpose

Oral antiseptic

Uses

For temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

Warnings

For oral use only

Allergy Alert

Do not use this product if you have a history of allergy to local anaesthetics, such as procaine, butacaine, benzocaine, or other “caine” anaesthetics due to the possibility of anaphylactic shock.

When Using This Product

Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

Keep Out Of Reach Of Children.

If more than used for pain relief and protection is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 years and older: dry affected area and apply medication undiluted; Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor
  • Consult a dentist or doctor for use on children under 2 years of age
  • Children under 12 years of should be supervised in the use of this product

Other Information

  • Do not use if packet is torn, cut or opened
  • Store at room temperature, 15° to 30°C (59° to 86°F)
  • Avoid contact with eyes

Inactive Ingredients

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

* Please review the disclaimer below.