Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Antispetic Mouthwash
FDA Label NDC 55910-099
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 55910-099). 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 active ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigingivitis, antiplaque
Use
help 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
- do not swallow
- not intended to replace brushing or flossing
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.
children under 12 years of age - consult a dentist or doctor
Other Information
cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59⁰ - 77⁰ F)
Inactive Ingredients
water, alcohol 21.6%, sorbitol solution, flavoring, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3
Disclaimer
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION.
This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Fresh Burst Listerine Antiseptic Mouthwash
Adverse Reactions
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
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(888)-309-9030
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Compare to
FreshBurst Listerine
Antiseptic Mouthwash
ANTISEPTIC
MOUTHWASH
Antigingivitis/Antiplaque
SPRING MINT
Kills germs that
cause bad breath,
plaque, and the gum disease gingivitis
250 mL (8.5 FL OZ)
Image Description (Mm1)
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