Tep
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Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 55301-072
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Your Military Exchanges for the product Antiseptic Mouth Rinse (NDC 55301-072). 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, claims, active ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Claims
Fights bad breath
For better oral hygiene
Active Ingredients
Eucalytpol 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 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 elp 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 those product. Its antiseptic properties are not affected. Store at room temperature (59⁰ -77⁰ F)
Inactive Ingredients
water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C Yellow no.10, FD&C green no.3
Disclaimer
This product is not manufactured or distributed by Johnson & Johnson Helathcare Products,
distributor of FreshBurst Listerine Antiseptic Mouthwash
Adverse Reactions Section
SATISFACTON GUARANTEED OR YOUR MONEY BACK
Manufactured For Your Military Exchanges
By: Vi-Jon, 8515 Page Avenue
St. Louis, MO 63114
072.002/072AL
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Spring Mint
ANTISEPTIC
MOUTHRINSE
ANTIGINGIVITIS/ANTIPLAQUE
Kills germs that cause bad breath, plaque and gingivitis gum disease
quaity value
1 L (33.8 FL OZ)
Image Description (Mm1)
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