FDA Label for Oral Care Antiseptic
View Indications, Usage & Precautions
Oral Care Antiseptic Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid. 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.
Tep
Sealed With Printed Neckband For Your Protection
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 periodontitis, a serious form of gum disease.
Stop Use And Ask A Dentist
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
0Ther 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 Rite Aid 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 distributed by Johnson & Johnson Healthcare Products, distributor of Listerine
Adverse Reaction
DISTRIBUTED BY:
RITE AID
30 Hunter Lane, Camp Hill, PA 17011
SATISFACTION
GUARANTEE
Learn more at
www.RiteAid.com
DSP-TN-15000
DSP-MO-34
SDS-TN15012
318.003/318AH
Principal Display Panel
RITE
AID
PHARMACY
COMPARE TO THE
ACTIVE INGREDIENTS IN lISTERINE
oral care
antiseptic
mouth rinse
original
ADA
Accepted
American
Dental
Association
kills germs that cause bad
breath, plaque and the gum
disease gingivitis
1 L (33.8 FL OZ)
* Please review the disclaimer below.