Tamper Evident Statement
Sealed with printed neckband for your protection
Cetylpyridinium Chloride Mouthwash
FDA Label NDC 75712-542
14 label sections · Submitted to the FDA by Old East Main Co. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Cetylpyridinium Chloride (NDC 75712-542). 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 tamper evident statement, active ingredient, purpose, use, warnings, stop use and ask a dentist if, keep out of reach of children under 6 years of age., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Cetylpyridinium Chloride 0.05%
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
Claims
- Defends against gum disease and gingivitis
- Helps prevent bleeding gums
- Made without artificial colors
Disclaimer
*This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of TheraBreath ® Dentist Formulated Healthy Gums Oral Rinse Clean Mint.
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DISTRIBUTED BY:
OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
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Since 1903
Rexall™
Compare to Therabreath ® Healthy Gums Oral Rinse Clean Mint*
Clean Gums
Oral Rinse
Antigingivitis/Antiplaque Mouthrinse
Clean Mint
Helps Fight Gingivitis For 12 Hours
- Fights Against Bad Breath
- Alcohol Free
- Dye Free
10 FL OZ (296 mL)
Mm01 (Mm01)
* Please review the disclaimer below.
