Safety Seal
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Rinse Mouthwash
FDA Label NDC 0363-0318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Rinse (NDC 0363-0318). 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 safety seal, active ingredients, purpose, use, warnings, do not use, stop use and ask a dentist, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 periodontist, a serious form of gum disease.
Stop Use And Ask A Dentist
gingivitis, bleeding, or redness persists for more thatn 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 teaspoonsfuls) 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 Council Statement
The ADA Council on Scientific Affairs Acceptance of Walgreens Original Antiseptc Mouth Rinse is based on the finding that the product is affective 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 Antiseptic
Questions
Questions or comments? 1-888-593-0593
Adverse Reactions
DISTRIUBTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
MADE IN U.S.A. WITH U.S. AD FOREIGN COMPONENTS
318.003/318AH
Principal Display Panel
Well at
Walgreens
ANTISEPTIC - ORIGINAL
Mouth Rinse
Kills germs that cause bad breath, plaque & the gum disease gingivitis
ADA
Accepted
American
Dental
Association
Compare to Listerine Antiseptic
Active ingredients
33.8 FL OZ (1 L)
Image Description (Mm3)
Image Description (Mm3)
* Please review the disclaimer below.
