FDA Label for Parodontax Active Gum Health Clear Mint
View Indications, Usage & Precautions
Parodontax Active Gum Health Clear Mint 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
Cetylpyridinium chloride 0.07% w/w
Purpose
Antigingivitis, Antiplaque
Uses
• gingivitis, an early form of gum disease• bleeding gums
Stop Use And Ask A Dentist If
• irritation occurs• 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 rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
• adults and children 6 years of age and older: measure twice up to 10 milliliters mark inside of cap. Vigorously swish 20 milliliters of the rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. Do not rinse with water. Do not drink from bottle.• children 6 years to under 12 years of age: supervisor use• children under 6 years of age: do not use
Other Information
• this rinse is not intended to replace brushing or flossing• may cause staining• Do not store above 25°C or 77°F
Inactive Ingredients (Mint)
Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1
Inactive Ingredients (Clear Mint)
Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid
Questions Or Comments?
1-855-328-5202
Additional Information
*Kills plaque bacteria associated with gingivitis and odor-causing bacteria in a laboratory test
Do not use if the printed seal on the cap
is broken or missing.
ALWAYS FOLLOW THE LABEL
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
Trademarks owned by or licensed by GSK.
©2021 GSK or licensor.
1-855-328-5202
Principal Display Panel
NDC 0135-0651-02
NEW
parodontax
CETYLPYRIDINIUM CHLORIDE ANTIGINGIVITIS/
ANTIPLAQUE MOUTHRINSE
ACTIVE GUM HEALTH
DAILY MOUTHWASH
TARGETS BACTERIA*
& FORMS AN
ANTIBACTERIAL SHIELD
MINT
KILLS 99.9%
PLAQUE
BACTERIA*
16.9 FL OZ (500 mL)
L0020006FA: Front Label
L0020006BA: Back Label
NDC 0135-0650-01
NEW
parodontax
CETYLPYRIDINIUM CHLORIDE ANTIGINGIVITIS/
ANTIPLAQUE MOUTHRINSE
ACTIVE GUM HEALTH
DAILY MOUTHWASH
TARGETS BACTERIA*
& FORMS AN
ANTIBACTERIAL SHIELD
CLEAR MINT
DYE FREE
ALCOHOL FREE
16.9 FL OZ (500 mL)
L0020007FA: Front Label
L0020007BA: Back Label
* Please review the disclaimer below.