NDC 35000-220 Colgate Renewal Whitening Restoration

Stannous Fluoride

NDC Product Code 35000-220

NDC 35000-220-32

Package Description: 1 TUBE in 1 CARTON > 90 g in 1 TUBE

NDC Product Information

Colgate Renewal Whitening Restoration with NDC 35000-220 is a a human over the counter drug product labeled by Colgate-palmolive Company. The generic name of Colgate Renewal Whitening Restoration is stannous fluoride. The product's dosage form is gel, dentifrice and is administered via dental form.

Labeler Name: Colgate-palmolive Company

Dosage Form: Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.

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.

Colgate Renewal Whitening Restoration 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.

  • STANNOUS FLUORIDE 1.1 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.

  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
  • POTASSIUM NITRATE (UNII: RU45X2JN0Z)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

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: Colgate-palmolive Company
Labeler Code: 35000
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: 11-03-2020 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 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.

Colgate Renewal Whitening Restoration Product Label Images

Colgate Renewal Whitening Restoration 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

Dist. by:COLGATE-PALMOLIVE CO.New York, NY 10022 U.S.A.

Active Ingredient

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

Anticavity, Antigingivitis, Antisensitivity

Uses

  • Aids in the prevention of cavitieshelps prevent gingivitishelps interfere with harmful effects of plaque associated with gingivitisbuilds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Otc - When Using

When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.

Otc - Stop Use

Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Otc - Keep Out Of Reach Of Children

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

Stop Use And Ask A Dentist If

  • Gingivitis, bleeding, or redness persists for more than 2 weeksyou have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.

Directions

  • Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.do not swallow.children under 12 years of age: consult a dentist.

Other Information

  • Products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.this Colgate product is specially formulated to help prevent staining.

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, PEG-12, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Potassium Nitrate, Xanthan Gum, Sodium Saccharin, Cocamidopropyl Betaine, Sodium Hyaluronate, Blue 1, Yellow 10.

Questions?

1-800-468-6502

* Please review the disclaimer below.