FDA Label for Antiseptic Mouth Rinse

View Indications, Usage & Precautions

Antiseptic Mouth Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Military Exchanges. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Tep



SEALED WITH PRINTED NECK BAND FOR YOUR PROTECTION


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


Principal Display Panel



Compare to FreshBurst Antiseptic Mouthwash

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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)


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