Tep
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Antispetic Mouthwash
FDA Label NDC 0363-0664
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Antispetic (NDC 0363-0664). 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, warning, do not use, stop use and ask a dentist if, 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
Warning
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 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 (59°-77°F)
Inactive Ingredients
water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3
Ada Council Statement
The ADA Council on Scientific Affairs Acceptance of Walgreens Fresh Mint Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plque above the gumline, when used as directed.
Disclaimer
This product is not manufactured or distribted by Johnson & Johnson Healthcare Products, distributor of Cool Mint Listerine Antiseptic Mouthwash.
Adverse Reactions
Questions or comments? 1-800-925-4733
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
WALGREENS.COM
2013 Walgreen Co.
MADE IN U.S.A. WITH U.S.
AND FOREIGN COMPONENTS
Principal Display Panel
Well at
Walgreens
ANTISEPTIC
Mouth Rinse
- Kills germs that cause bad breath, laque & the gum disease gngivitis
ADA
Accepted
American
Dental Association
FRESH MINT
Compare to Listerine Cool Mint
Antiseptic Mouthwash active ingredients
33.8 FL OZ (1 L)
Image Description (Mm3)
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