NDC 0135-0632 Sensodyne Rapid Relief

Stannous Fluoride

NDC Product Code 0135-0632

NDC 0135-0632-01

Package Description: 1 TUBE in 1 CARTON > 96.4 g in 1 TUBE

NDC Product Information

Sensodyne Rapid Relief with NDC 0135-0632 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Sensodyne Rapid Relief is stannous fluoride. The product's dosage form is paste and is administered via oral form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Sensodyne Rapid Relief 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

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: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 07-08-2019 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.

Sensodyne Rapid Relief 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

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

Purposes

Anticavity, Antihypersensitivity

Uses

  • •aids in the prevention of dental cavities. •builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

When Using This Product,

If irritation occurs discontinue use.

Stop Use And Ask A Dentist If

  • •the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. •pain/sensitivity still persists after 4 weeks of use.

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.

Directions

  • •adults and children 12 years of age and older: •apply at least a 1-inch strip of the product onto a soft bristle toothbrush •brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. •children under 12 years of age: Consult a dentist or doctor.

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 product is specifically formulated to help prevent staining •store below 25°C (77°F)

Inactive Ingredients (Extra Fresh)

Glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Inactive Ingredients (Mint)

Glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

* Please review the disclaimer below.