Active Ingredients
Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%
Original Antiseptic Mouthwash
FDA Label NDC 36800-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Original Antiseptic (NDC 36800-318). 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 ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children, directions, 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 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)
Image Description (Mm3)
Image Description (Mm3)
* Please review the disclaimer below.
