FDA Label for Antigingivitis/antiplaque
View Indications, Usage & Precautions
Antigingivitis/antiplaque Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates 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.
Tamper Evident Statement
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Disclaimer
QUALITY GUARANTEED
This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurance.
*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ®Pro-Health ®CPC Antigingivitis/Antiplaque Oral Rinse Gum and Breath Purify Smooth Mint.
Active Ingredient
Cetylpyridinium Chloride 0.07%
Purpose
Antigingivitis, Antiplaque
Use
helps control plaque 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, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1
Adverse Reaction
DISTRIBUTED BY TOPCO ASSOCIATED LLC, ITASCA, IL 60143
©TOPCO VIJA1123 QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
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Principal Display Panel
COMPARE TO CREST ® PRO-HEALTH ® ORAL RINSE GUM AND BREATH PURIFY*
TopCare ®everyday
ALCOHOL FREE
Gum Defense
Antigingivitis/Antiplaque
Oral Rinse
SMOOTH MINT
- Helps improve gum hygiene
- CPC antigingivitis/antiplaque oral rinse
- kills germs that cause bad breath
- helps defend against early signs of gum disease
IMPORTANT: Read directions for proper use.
1L (1QT 1.8 FL OZ) 33.8 FL OZ)
* Please review the disclaimer below.
