Tep
Sealed With Printed Neckband for your protection
Antispetic Mouthwash
FDA Label NDC 55910-664
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Antispetic (NDC 55910-664). 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 ingredient, purpose, use, warnings, 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 Ingredient
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
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 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) between teeth for 30 seconds then spit out.
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 solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3
Disclaimer
This product is not manufactured or distributed by Johnson & Johnson Healthcare products, distributor of Cool Mint Listerine Antiseptic Mouthwash
DSP-TN-15000
DSP-MO-34
SDS-TN-15012
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Adverse Reactions
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
Principal Display Panel
DG health
Compare to
Cool Mint
Listerine Antiseptic
Mouthwash
ANTISEPTIC
MOUTHASH
Antigingivitis/Antiplaque
BLUE MINT
Kills germs that
cause bad breath,
plaque, and the gum
disease gingivitis
Sealed with printed neckband for your protection
1.5L (50.7 FL OZ)
Image Description (Mm3)
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