Tamper Evident Statement
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Antigingivitis/antiplaque Mouthwash
FDA Label NDC 79481-0953
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Antigingivitis/antiplaque (NDC 79481-0953). 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, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, cinnamal, blue 1, yellow 6
Disclaimer
This may cause temporary staining to the surface of teeth.
This is not harmful, and adequate brushing may prevent its occurrence.
*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest® Pro-Health® Intense Clean Mint Mouthwash.
Claims
^Kills at least 99% of many organisims commony associated with bad breath in as little as 15 seconds.
Other
DISTRIBUTED BY
MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com
OUR QUALITY GUARANTEE
The Meijer Family
WWW.MEIJER.COM/SATISFACTION
Principal Panel Display
meijer
COMPARE TO CREST® PRO-HEALTH® INTENSE CLEAN ACTIVE INGREDIENT*
Powerful Fresh Mouthwash
ANTIGINGIVITIS/ANTIPLAQUE
COOLING
FRESH MINT
Helps prevent plaque and gingivitis
Kills 99% of many bad breath germs^
Helps keeps teeth clean
Sugar & paraben free
1 L (1.5 QT) 33.8 FL OZ
Image Description (Mm01)
* Please review the disclaimer below.
