FDA Label for Antiseptic

View Indications, Usage & Precautions

Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Onpoint, Inc. 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.

Otc - Active Ingredient



Active ingredientsEucalyptol 0.092%  Menthol 0.024%Methyl salicylate 0.060%  thymol 0.064%

Otc - Purpose



PurposeAntigingivitis, 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 guns, pus from the gum line, loose teeth or increased spacing betweenthe 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, getmedical help or contact a Poison Control Center right away.

Dosage & Administration



Directionsadults 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•this rinse is not intended to replace brushing or flossing

Storage And Handling



Other information cold weather may cloud this product.  Its antiseptic propertied are not affected.  Store at room temperature (59⁰-77⁰F).

Inactive Ingredient



Inactive ingredients water, alcohol (21.6%), sorbitol solution, flavoring, PEG-40 hydrogenated castor oil, poloxamer 407, benzoic acid, zinc chloride, sucralose and/or sodium saccharin, sodium benzoate, yellow 6, red 40

Other



This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of ListerineDSP-TN-15000DSP-MO-34SDS-TN-15012

Package Label.Principal Display Panel



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTIONLive BetterAntisepticMouthRinseCITRUSADVANCEDTARTAR CONTROLCompare to Citrus Advanced Listerinewith Tartar Protection•HELPS FIGHT TARTAR BUILDUP  FOR BRIGHTER TEETH•FIGHTS PLAQUE AND GINGIVITIS•KILLS GERMS FOR EXTENDED  PLAQUE PROTECTION•ENHANCED BREATH PROTECTION1L (33.8 FL OZ)

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