NDC 76484-948 20/20 Topical Anesthetic

NDC Product Code 76484-948

NDC 76484-948-24

Package Description: 1 CASE in 1 POUCH > 24 STRIP in 1 CASE

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

NDC Product Information

20/20 Topical Anesthetic with NDC 76484-948 is a product labeled by Advanced Dental Anesthetics. The generic name of 20/20 Topical Anesthetic is . The product's dosage form is and is administered via form.

Labeler Name: Advanced Dental Anesthetics

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.

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.

  • HYPROMELLOSE 2208 (3 MPA.S) (UNII: 9H4L916OBU)
  • HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
  • HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • ACACIA (UNII: 5C5403N26O)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)

Product Labeler Information

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

Labeler Name: Advanced Dental Anesthetics
Labeler Code: 76484
Start Marketing Date: 02-28-2012 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: E 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.

20/20 Topical Anesthetic Product Label Images

20/20 Topical Anesthetic 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

Storage conditions: 55° to 78° Fahrenheit in a dry place. Keep foil pouch for information. KEEP AWAY FROM LIGHT

Distributed by:AdvancedDENTAL ANESTHETICS

Active Ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Use

Temporary relief of oral pain

Otc - Ask Doctor/Pharmacist

Consult a physician or qualified health care professional prior to using this product if you have any medical conditions, or if you are using any prescription drug.

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.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.This carrying case may present a choking hazard. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

Stop Use And Ask Doctor If

  • Swelling, rash or fever developsirritation, pain or redness persists or worsenssymptoms do not improve in 7 days

Directions

  • Not for use by individuals under 12 years of age.Dosage: 1 strip, not more than 4 per dayRemove 1 strip from carrying case.Place strip onto area of desired anesthesiaAllow strip to dissolve completely

Inactive Ingredients

Hydroxypropyl Methyl Cellulose, Gylcerine, Peppermint Oil Flavor, Gum Arabic, Sodium Carboxy Methyl Cellulose, Sucralose, Polysorbate 80, Sodium Copper Chlorophyllin.

* Please review the disclaimer below.