Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Antispetic Mouthwash
FDA Label NDC 67091-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Antispetic (NDC 67091-103). 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
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
- this rinse is not intended to replace brushing or flossing
Other Information
cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59° -77°F)
Inactive Ingredients
water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3
Questions
Or to report an adverse event call 800-824-1706
Monday - Friday 9am - 4pm MST
Ada Council Statement
"The ADA Council on Scientific Affairs' Acceptance of WinCo Foods Blue Mint 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 Cool Mint LISTERINE Antiseptic Mouthwash.
Adverse Reactions
DISTRIBUTED BY: WINCO FOODS, LLC, BPOSE, ID 83704
664.001/664AR
Principal Display Panel
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Compare to the active ingredients in
Cool Mist LISTERINE Antiseptic Mouthwash
WinCo
FOODS
ANTISEPTIC
MOUTH RINSE
ANTIGINGIVITIS/ANTIPLAQUE
MOUTH RINSE
Kills Germs That Cause Bad Breath,
Plaque and Gingivitis Gum Disease
For Better Oral Hygiene and
Fresher Breath
ADA
Accepted
American
Dental
Association
Blue Mint
33.8 FL OZ (1 QT 1.8 FL OZ) 1 L
Image Description (Mm3)
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