FDA Label for Original Antiseptic
View Indications, Usage & Precautions
Original Antiseptic 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.
Active Ingredients
Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%
Purpose
Antigingivitis, Antiplaque
Use
helps control plaque that leads to gingivitis
Warnings
for this product
Do Not Use
if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.
Stop Use And Ask A Dentist If
gingivitis, bleeding, or redness persists for more than 2 weeks
Keep Out Of Reach Of Children
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- do not swallow
- not intended to replace brushing or flossing
adults and children 12 years of age and older vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow
children under 12 years of age consult a dentist or doctor
Other Information
Store at room temperature (59°-77°F).
Inactive Ingredients
water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel
Ada Council Statement
The ADA Council on Scientific Affairs’ Acceptance of TopCare Amber Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.”
Disclaimer
This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine
Adverse Reactions
DISTRIBUTED BY: TOPCO ASSOCIATES LLC
7711 GROSS POINT ROADK, SKOKIE, IL 60077
TOPCO CSW1006
QUESTIONS? 1-888-423-0139 [email protected]
318.003/318AH
Principal Display Panel
Sealed With Printed Neckband For Your Protection
TOP CARE
AMBER
Antiseptic
Mouth
Rinse
ADA
Accepted
American
Dental
Association
Kills Germs that Cause
Bad Breath,
Plaque, & the
Gum Disease
Gingivitis
QUALITY GUARANTEED
COMPARE TO LISTERINE
active ingredients
1.5 LITERS (50.7 FL OZ)
* Please review the disclaimer below.
