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  5. Label Information: Parodontax Active Gum Repair Breath Freshener

FDA Label for Parodontax Active Gum Repair Breath Freshener

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSES
    3. USES
    4. STOP USE AND ASK A DENTIST IF
    5. KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS?
    10. ADDITIONAL INFORMATION
    11. PRINCIPAL DISPLAY PANEL

Parodontax Active Gum Repair Breath Freshener Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.

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:
  • •brush teeth thoroughly, preferably after each meal or 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, zinc chloride, carrageenan


Questions Or Comments?



1-855-328-5202


Additional Information



ALWAYS FOLLOW THE LABEL

parodontax ACTIVE GUM REPAIR
Bleeding gums and bad breath can be a sign of early gum problems.

New parodontax Active Gum Repair Breath Freshener is a daily toothpaste that helps reverse signs of early gum damage and uses Breath Cleanse Technology* to purify bad breath instead of just masking it.

  • •It is specially formulated to kill plaque bacteria at the gumline to help

    keep the gum seal tight and prevent early gum problems.

  • •Its Breath Cleanse Technology* utilizes zinc, an antibacterial ingredient

    scientifically proven to purify gases that cause bad breath.

    • *compared to parodontax Clean Mint toothpaste

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059 Made in Germany

    Trademarks owned or licensed by GSK. ©2023 GSK or licensor.


Principal Display Panel



NEW

parodontax

DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

ACTIVE GUM REPAIR

HELPS REVERSE SIGNS OF EARLY GUM DAMAGE

BREATH FRESHENER

BREATH CLEANSE TECHNOLOGY*

NET WT 3.4 OZ (96.4 g)

62000000203673 – Front Carton


* Please review the disclaimer below.