Otc - Active Ingredient
Active ingredientsEucalyptol 0.092%, Menthol 0.042%Methyl salicylate 0.060%, Thymol 0.064%
Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 11344-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Antiseptic Mouth Rinse (NDC 11344-318). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PurposeAntiginvitis, Antiplaque
Indications & Usage
Use helps control plaque that leads to gingivitis
Warnings
Warnings
Otc - Do Not Use
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.
Otc - Stop Use
Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks
Otc - Keep Out Of Reach Of Children
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
Dosage & Administration
Directions • this rinse is not intended to replace brushing or flossingadults 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 swallowchildren under 12 years of age - consult a dentist or doctor
Storage And Handling
Other information cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59⁰-77⁰F)
Inactive Ingredient
Inactive ingredients water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel
Other
DSP-TN-15000DSP-MO-34SDS-TN-15012
Adverse Reactions
Distributed by:Vi-JonSt. Louis, Missouri 63114Questions 1-888-593-0593
Package Label.Principal Display Panel
Child-Resistant CapSEALED WITH PRINTED NECKBANDFOR YOUR PROTECTIONAmberAntisepticMouth RinseKills germs that cause Plaque,Gingivitis and Bad Breath1.5 L (50.7 FL OZ)
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