FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredientsEucalyptol 0.092%, Menthol 0.042% Methyl salicylate 0.060%, Thymol 0.064%
Otc - Purpose
Indications & Usage
Use helps control plaque that leads to gingivitis
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 you 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
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 of flossing
Storage And Handling
Other information cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (57⁰-77⁰F)
Inactive ingredients water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin,sodium benzoate, FD+C green no. 3
The ADA council on Scientific affairs Acceptance of Sunmak's Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline when used as directed.This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Listerine.
Another Quality ProductDistributed by McKessonOne Post StreetSan Francisco, CA 94104Money Back QuaranteePlease visit us atwww.sunmarkbrand.comDSP-TN-15000DSP-MO-34SDS-TN-15012
Package Label.Principal Display Panel
SUNMARKCompare toListerineActive IngredientsNDC 49348-482-62MOUTHRinseAntisepticADAAcceptedKills germs that causebad breath, plaque + thegum disease gingivitisBLUE MINT33.8 FL OZ ( 1 L)
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