NDC 66467-8003 Darby Apf Strawberry

Sodium Fluoride

NDC Product Code 66467-8003

NDC CODE: 66467-8003

Proprietary Name: Darby Apf Strawberry What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sodium Fluoride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

  • 66467 - Darby Dental Supply, Llc

NDC 66467-8003-2

Package Description: 125 g in 1 CAN

NDC Product Information

Darby Apf Strawberry with NDC 66467-8003 is a a human prescription drug product labeled by Darby Dental Supply, Llc. The generic name of Darby Apf Strawberry is sodium fluoride. The product's dosage form is aerosol, foam and is administered via dental form.

Labeler Name: Darby Dental Supply, Llc

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

Product Type: Human Prescription 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.

Darby Apf Strawberry 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.

  • SODIUM FLUORIDE 2.72 g/100g

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.

  • WATER (UNII: 059QF0KO0R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • STRAWBERRY (UNII: 4J2TY8Y81V)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)

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.
  • Dental - Administration to a tooth or teeth.

Product Labeler Information

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

Labeler Name: Darby Dental Supply, Llc
Labeler Code: 66467
Marketing Category: UNAPPROVED DRUG OTHER - 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: 10-29-2019 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: 12-31-2020 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 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.

Darby Apf Strawberry 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

Strawberry

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

Directions For Use

L. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.

L. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.

L. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.

Medical Ingredients

Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride).

Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride).

Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride).

Non-Medical Ingredients

Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, strawberry flavor.

Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, mint flavor.

Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, bubble gum flavor.

Warnings

KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken.

KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken.

KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken.

Other

To reorder: Call 800.645.2310 or visit darby.com Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753NDC 66467-8003∙2Reorder# 95100501900196

To reorder: Call 800.645.2310 or visit darby.com Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753NDC 66467-8004∙2Reorder# 95100511900197

To reorder: Call 800.645.2310 or visit darby.com Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753NDC 66467-8005∙2Reorder# 95100521900198

Mint

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

Bubble Gum

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

* Please review the disclaimer below.