Tep
Sealed with printed neckband for your protection
Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 21130-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands, Llc for the product Antiseptic Mouth Rinse (NDC 21130-318). 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 chrildren, 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 periodtitis, 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 Chrildren
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 (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 Safeway Care Amber Antiseptic Mouthwash is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used at directed.
Disclaimer
This product is manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine
Adverse Reaction
DISTRIBUTED BY SAFEWAY INC.
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-SAFEWAY www.safeway.com
318.003/318AH
Principal Display Panel
SAFEWAY
CARE
Quality Guaranteed
ANTISEPTIC
Mouthwash
antigingivitis/antiplaque
Amber
Fights Plaque & Gingivitis
Compare to the active ingredients of listerine
ADA
Accepted
American
Dental
Association
1 L
(33.8 FL OZ)
* Please review the disclaimer below.
