NDC 0135-0634 Parodontax Complete Protection

Product Information

Product Code0135-0634
Proprietary Name 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.
Parodontax Complete Protection
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Glaxosmithkline Consumer Healthcare Holdings (us)
Labeler Code0135
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-06-2020
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
I
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325)

Product Packages

NDC 0135-0634-01

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Parodontax Complete Protection is product labeled by Glaxosmithkline Consumer Healthcare Holdings (us). The product's dosage form is and is administered via form.


What are Parodontax Complete Protection Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • STANNOUS FLUORIDE (UNII: 3FTR44B32Q)
  • FLUORIDE ION (UNII: Q80VPU408O) (Active Moiety)


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)


* Please review the disclaimer below.

Parodontax Complete Protection Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



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


Purposes



Anticavity

Antigingivitis


Uses



  • •aids in the prevention of dental cavities.
  • •helps control bleeding gums.
  • •helps interfere with harmful effects of plaque associated with gingivitis.

When Using This Product,



if irritation occurs discontinue use.


Stop Use And Ask A Dentist If



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

Keep Out Of Reach Of Children Under 6 Years 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 years of age and older:
  • •apply toothpaste onto a toothbrush.
  • •brush teeth thoroughly, preferably after each meal at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
  • •to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
  • children under 2 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 specially formulated to help prevent staining.
  • •do not store above 25°C (77°F)

Inactive Ingredients



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


Questions Or Comments?



1-855-328-5202

ALWAYS FOLLOW THE LABEL


Principal Display Panel



NDC 0135-0634-01

parodontax

COMPLETE PROTECTION

WHITENING

DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

HELPS PREVENT BLEEDING GUMS

∙FRESHENS BREATH ∙STRENGTHENS ENAMEL ∙DEEP CLEAN ∙WHITENS

∙REDUCES BLEEDING GUMS ∙REDUCES INFLAMED GUMS ∙REMOVES PLAQUE ∙GUM SEAL

NET WT

3.4 OZ (96.4 g)

parodontax

COMPLETE PROTECTION

Helps prevent bleeding gums

Healthy gums provide a foundation for strong teeth.

If you see occasional traces of blood when you brush, it could be a sign of unhealthy gums, eventually weakening that foundation.

New parodontax Complete Protection brings together the expertise behind our specialist gum toothpaste with all you need to help keep your teeth strong, giving you 8 benefits for healthier gums and stronger teeth.

GENTLY WHITENS

DEEP CLEANS

WORKS TO KEEP THE SEAL BETWEEN GUMS AND TEETH TIGHT

REDUCES RED AND INFLAMED GUMS

STRENGTHENS AND PROTECTS ENAMEL

FRESHENS BREATH

HELPS PREVENT BLEEDING GUMS

  •  EFFECTIVELY REMOVES PLAQUE
  • Trademarks are owned by or licensed to the GSK group of companies.

    ©2019 GSK group of companies or its licensor.

    •  Distributed by:
    • GSK Consumer Healthcare

      Warren, NJ 07059

      1000332


* Please review the disclaimer below.