Active Ingredient
Cetylpyridinium Chloride 0.05%
Cetylpyridinium Chloride Liquid
FDA Label NDC 56062-542
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc. for the product Cetylpyridinium Chloride (NDC 56062-542). 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, purpose, use, warnings, 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
Purpose
Antigingivitis, Antiplaque
Use
helps control plaque {bacteria} that leads to gingivitis
Warnings
for this product
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 increased 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 & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
- do not swallow
- children 6 years to under 12 years of age: supervise use
- when used after brushing, rinse mouth with water first
- children under 6 years of age: do not use
Other Information
- this rinse is not intended to replace brushing or flossing
Inactive Ingredients
water, glycerin, poloxamer 407, flavor, sucralose, benzoic acid, sodium benzoate
Questions Or Comments?
Call 1-888-267-3037
Disclaimer
*This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of TheraBreath ® Healthy Gums Oral Rinse Clean Mint.
Adverse Reaction
DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.
3300 PUBLIX CORPORATE PARKWAY,
LAKELAND, FL 33811
publix.com
PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK.
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Publix ®
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ALCOHOL-FREE
CLEAN MINT
Clean Gums
ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE
Helps fight gingivits for 12 hours.
Dye-free.
Compare to TheraBreath ® Healthy Gums Oral Rinse Clean Mint.*
Sealed with printed neckband for your protection.
16 FL OZ (1 PT) 473 mL
Mm01 (Mm01)
* Please review the disclaimer below.
