Parodontax Paste
FDA Label NDC 0135-0634

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Parodontax (NDC 0135-0634). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purposes, uses, when using this product,, stop use and ask a dentist if, keep out of reach of children under 6 years of age., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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    ©2019 GSK group of companies or its licensor.

    •  Distributed by:

      • GSK Consumer Healthcare

      Warren, NJ 07059

      1000332

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