The following Structured Product Label (SPL) was submitted to the FDA by Publix Supermarkets, Inc for the product Advanced Citrus Antiseptic (NDC 41415-210). 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.
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
PublixADVANCEDCitrusANTISEPTIC MOUTH RINSE•helps fight tartar buildup•fights plaque and Gingivitis•kills germs for extended plaque protection•enhanced breath protectionCOMPARE TO CITRUS ADVANCED LISTERINE WITH TARTAR PROCTECTIONSEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION1L (33.8 FL OZ)
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