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 Wakefern Food Corporation. 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 For This Product
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
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 (59⁰ - 77⁰F)
Inactive Ingredients
water, alcohol 21.6%, sorbitol solution, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D+C yellow no. 10, FD+C green no.3
Ada Statement
The ADA Council on Scientific Affairs Acceptance of Shop Rite Spring Mint Antiseptic Mouth Rinse is based on its finding that the product is effective in helping 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 FreshBurst Listerine Antiseptic Mouthwash
DSP-TN-15000
DSP-MO-34
SDS-TN-15012
Adverse Reactions
Distributed By:
Wakefern Food Corp
5000 Riverside Drive
Keasbey, NJ 08832
Call: 1-800-SHOPRITE
Email: www.shoprite.com
Principal Display Panel
Compare to Fresh Burst Listerine*
Price Rite
Antiseptic Mouthrinse
Antigingivitis/Antiplaque
Fresh Mint
Helps to kill germs that cause plaque,gingivitis and bad breath
Sealed With Printed Neckband For Your Protection
1 L (33.8 FL OZ)
* Please review the disclaimer below.