Tep
Sealed With Printed Neckband For Your Protection
Oral Care Antiseptic Mouthwash
FDA Label NDC 11822-3108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Oral Care Antiseptic (NDC 11822-3108). 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 tep, 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 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
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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)
Image Description (Mm3)
Image Description (Mm3)
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