Active Ingredients
Eucalyptol 0.092%, Menthol 0.042% Methyl salicylate 0.060%, Thymol 0.064%
Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 68016-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Antiseptic Mouth Rinse (NDC 68016-318). 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
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
Adult and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonsful) 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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel
Ada Statement
"The ADA council on Scientific Affairs Acceptance of Premier Value Original 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 directed by Johnson & Johnson Healthcare Poroducts, distributor of Original Listerine Antiseptic Mouthwash
Adverse Reactions
DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431
318.003/318AH
Package Label
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
COMPARE TO ORIGINAL LISTERINE ANTISEPTIC MOUTHWASH
Premier
Value
Antiseptic
Mouthrinse
Antigingivitis/Antiplaque
original
kills germs that cause
bad breath, plaque & the
gum disease gingivitis
ADA
Accepted
American
Dental
Association
1 L (33.8 FL OZ)
Image Description (Mm3)
Image Description (Mm3)
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