Active Ingredient
Cetylpyridinium chloride 0.07% w/w
Parodontax Liquid
FDA Label NDC 0135-0652
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 0135-0652). 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, stop use and ask a dentist if, keep out of reach of children under 6 years of age., directions (500 ml), directions (1000 ml), other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Antigingivitis, Antiplaque
Uses
helps prevent and reduce plaque that leads to
■ 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 (500 Ml)
■ 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 the bottle.
■ children 6 years to under 12 years of age: supervise use
■ children under 6 years of age: do not use
Directions (1000 Ml)
■ adults and children 6 years of age and older: vigorously swish 20 milliliters (4 teaspoonfuls) of 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 the bottle. ■ children 6 years to under 12 years of age: supervise use
■ children under 6 years of age: do not use
Other Information
■ this product is not intended to replace brushing or flossing
■ may cause staining
■ do not store above 25°C (77°F)
Inactive Ingredients
water, glycerin, poloxamer 407, flavor, benzoic acid, sodium benzoate, sucralose, zinc lactate, sodium saccharin, green 3, yellow 6, cinnamal
Questions Or Comments?
1-866-844-2797
Generic Section
ALWAYS FOLLOW THE LABEL
Do not use if printed safety seal around cap is broken or missing.
Pat. Info www.productpats.com
Distributed by: Haleon, Warren, NJ 07059
Trademarks owned or licensed by Haleon.
©2023 Haleon or licensor.
*Kills plaque bacteria associated with gingivitis and odor-causing bacteria in a laboratory test
BOTTLE
RECYCLE
CAP
CHECK LOCALLY
†Recycling facilities for this product may not exist in your area
206167
L0021380BA
Principal Display Panel
NEW
HALEON
parodontax
CETYLPYRIDINIUM CHLORIDE
ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE
DAILY MOUTHWASH
HELPS PREVENT
BLEEDING GUMS
& BAD BREATH
BACTERIA
BREATH CLEANSE TECHNOLOGY
BREATH FRESHENER
KILLS 99.9%
PLAQUE BACTERIA*
ALCOHOL FREE
NET WT 16.9 FL OZ (500 mL)
206166
L0021380FA
* Please review the disclaimer below.
