NDC 67751-095 Handy Solutions Crest Complete Multi-benefit Whitening Plus Scope

Sodium Fluoride

NDC Product Code 67751-095

NDC CODE: 67751-095

Proprietary Name: Handy Solutions Crest Complete Multi-benefit Whitening Plus Scope 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.

Product Characteristics

Color(s):
GREEN (C48329)
Flavor(s):
PEPPERMINT (C73408)

NDC Code Structure

NDC 67751-095-01

Package Description: 1 TUBE in 1 PACKAGE > 24 g in 1 TUBE

NDC 67751-095-03

Package Description: 1 TUBE in 1 PACKAGE > 43 g in 1 TUBE

NDC 67751-095-04

Package Description: 1 TUBE in 1 PACKAGE > 113 g in 1 TUBE

NDC Product Information

Handy Solutions Crest Complete Multi-benefit Whitening Plus Scope with NDC 67751-095 is a a human over the counter drug product labeled by Navajo Manufacturing Company Inc. The generic name of Handy Solutions Crest Complete Multi-benefit Whitening Plus Scope is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 891775.

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

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.

Handy Solutions Crest Complete Multi-benefit Whitening Plus Scope 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.

  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ALCOHOL (UNII: 3K9958V90M)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Navajo Manufacturing Company Inc
Labeler Code: 67751
FDA Application Number: part355 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 08-16-2013 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: 12-31-2021 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.

Information for Patients

Fluoride

Fluoride is pronounced as (floor' ide)

Why is fluoride medication prescribed?
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usu...
[Read More]

* Please review the disclaimer below.

Handy Solutions Crest Complete Multi-benefit Whitening Plus Scope 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

Active Ingredient

Sodium fluoride 0.243%

Purpose

Anti-Cavity toothpaste

Use

Helps protect against cavities

Keep Out Of Reach Of Children Under 6 Yrs. Of Age.

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

Directions

  • Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentistdo not swallowto minimize swallowing use a pea-sized amount in children under 6supervise children's brushing until good habits are establishedchildren under 2 years : ask a dentist

Inactive Ingredients

Sorbitol, water, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, alcohol (0.7%), xanthan gum, sodium saccharin, glycerin, carbomer, cellulose gum, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

Handy Solutions Crest Complete Multi-Benefit Whitening Plus Scope

Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope 24g     (67751-095-01)


Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope 48g    (67751-095-03)


Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope 113g    (67751-095-04)

* Please review the disclaimer below.