PARODONTAX ACTIVE GUM REPAIR BREATH FRESHENER- stannous fluoride paste

parodontax by

Drug Labeling and Warnings

parodontax by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Warnings

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 25ºC (77ºF)

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?

1-855-844-2797

Additional information

ALWAYS FOLLOW THE LABEL

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

parodontax Active Gum RepairBreath Freshener is a daily fluoride toothpaste that reduces signs of early gum disease and uses Breath Cleanse Technology to purify bad breath instead of just masking it. Specially formulated to kill plaque bacteria at the gumline to help keep the gum seal tight.

Its Breath Cleanse Technology utilizes zinc, an ingredient clinically proven to purify the gases that cause bad breath.

*vs. a regular toothpaste used by people who have gingivitis

Targets plaque bacteria

Fights early gum problems

Reduces bad breath

Breathcleanse TECHNOLOGY

Principal Display Panel

NEW LOOK

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

ACTIVE GUM REPAIR

BREATH FRESHENER

CLINICALLY PROVEN TO REDUCE SIGNS OF EARLY GUM DISEASE*:

✓ BLEEDING ✓ REDNESS ✓ SWELLING ✓BAD BREATH

breathcleanse

TECHNOLOGY

NET WT 3.4 OZ (96.4 g)

INGREDIENTS AND APPEARANCE

PARODONTAX  ACTIVE GUM REPAIR BREATH FRESHENER
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0737
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)
ZINC CHLORIDE (UNII: 86Q357L16B)
CARRAGEENAN (UNII: 5C69YCD2YJ)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0737-01	1 in 1 CARTON	01/02/2024
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0737-02	1 in 1 CARTON	01/02/2024
2		23 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0135-0737-03	1 in 1 CARTON	01/02/2025
3		65 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/02/2024

Labeler - Haleon US Holdings LLC (079944263)