NDC 60630-077 Dentek Instant Pain Relief Maximum Strength

NDC Product Code 60630-077

NDC 60630-077-02

Package Description: 1 VIAL, GLASS in 1 CARTON > 3.7 mL in 1 VIAL, GLASS (60630-077-01)

NDC 60630-077-04

Package Description: 1 VIAL, GLASS in 1 CARTON > 3.5 mL in 1 VIAL, GLASS (60630-077-03)

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Dentek Instant Pain Relief Maximum Strength with NDC 60630-077 is a product labeled by Dentek Oral Care. Inc.. The generic name of Dentek Instant Pain Relief Maximum Strength is . The product's dosage form is and is administered via form.

Labeler Name: Dentek Oral Care. Inc.

Dosage Form: -

Product Type: 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.

Dentek Instant Pain Relief 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.

  • BENZOCAINE 200 mg/mL

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.

  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Administration Route(s)

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

  • Dental - Administration to a tooth or teeth.
  • 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: Dentek Oral Care. Inc.
Labeler Code: 60630
Start Marketing Date: 02-01-2014 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: 12-31-2017 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: I 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.

Dentek Instant Pain Relief 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

Otc - Active Ingredient

Active ingredientsBenzocaine 20%

Otc - Purpose

PurposeOral Pain Reliever

Indications & Usage

Use for the temporary relief of pain due to:
. toothaches
. canker sore
. cold sores
. sore gums

Warnings

WarningsAllergy alert: do not use this product if you have a history of allery to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Otc - When Using

When using this product . avoid contact with the eyes
. do not exceed recommended dosage
. do not use for more than 7 days unless directed by a doctor/dentist

Otc - Stop Use

Stop use and ask a dentist or doctor if. swelling, rash or fever develops
. irritation, pain or redness persists or worsens
. symptoms do not improve in 7 days

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions. dip applicator into liquid
Adults and children 2 years of age and older: Apply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
Children under 12 years of age: Should be supervised in the use of this product.
Children under 2 years of age: Ask a dentist or doctor.

Other Safety Information

Other information . do not use if safety seal on carton is broken.
. this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted.
. do not use continuously

Inactive Ingredient

Inactive ingredients: Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

Otc - Questions

Questions or comments? Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at info@DenTek.com

* Please review the disclaimer below.