The following Structured Product Label (SPL) was submitted to the FDA by Drug Mart for the product Advanced Antiseptic Citrus (NDC 53943-210). 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 0.042%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 gums, puss from the gum line, loose teeth or increased spacing between the teeth. See yourdentist 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
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 reinse is not intended to replace brushing or flossing
Storage And Handling
Other information cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59⁰- 77⁰ F)
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
Adverse Reactions
DISTRIBUTED BYDRUG MART-FOOD FAIRMEDINA, OHIO 44256WWW.DISCOUNT-DRUGMART.COM
Package Label.Principal Display Panel
DiscountDrugMartFood FairCitrusAntisepticMouth Rinsewith Tartar ProtectionHELPS FIGHT TARTAR BUILDUPFIGHTS PLAQUE AND GINGIVITISKILLS GERMS FOR EXTENDEDPLAQUE PROTECTIONENHANCED BREATH PROTECTIONCompare To CitrusAdvanced Listerinewith Tartar ProtectionSEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION500 mL (16.9 FL OZ)
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