FDA Label for Antiseptic Mouth Rinse
View Indications, Usage & Precautions
Antiseptic Mouth Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens Co.. 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
Warnings
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.
Of 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. It antiseptic properties are not affected. Store at room temperature (59⁰ - 77⁰ F)
Inactive Ingredients
water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D+C yellow no. 10, FD+C green no.3
Other
The ADA Council on Scientific Affairs Acceptance of Wallgreens Spring 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.
This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine Fresh Burst
DSP-TN-1500 DSP-MO-34 SDS-TN-15012
Principal Display Panel
WELL at Walgreens
ANTISEPTIC Mouth Rinse
- Freshens breath
- Improves oral hygiene
- Alcohol 21.6%
ADA Accepted American Dental Association
Spring Mint
Compare to Listerine Fresh Burst Active ingredients
16.9 FL OZ (500 mL)
072.002/072AL
* Please review the disclaimer below.