FDA Label for Advanced Antiseptic
View Indications, Usage & Precautions
Advanced Antiseptic Product Label
The following document was submitted to the FDA by the labeler of this product Wakefern Food Corporation. 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 0.042%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, 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, 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 rinse is not intended to replace brushing of flossing
Storage And Handling
Other information could weather may cloud this product. Its antiseptic properties 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
Adverse Reactions
DISTRIBUTED BY WAKEFERN FOOD CORPORATION5000 RIVERSIDE DRKEASBEY, NJ 088321-800-SHOPRITEwww.shoprite.com
Package Label.Principal Display Panel
Compare to Citrus Advanced Listerinewith Tartar ProtectionShop RiteAdvancedAntisepticMouth Rinsewith Tartar ProtectionHelps to kill germsthat cause plaque,gingivitis and bad breathCITRUSSEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION1.5 L (50.7 FL OZ)
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