Otc - Active Ingredient
Active ingredientsEucalyptol 0.092% Menthol 0.042%Methyl salicylate 0.060% Thymol 0.064%
Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 36800-072
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Antiseptic Mouth Rinse (NDC 36800-072). 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.
Label Section Quick Index
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 between the 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 or flossing
Storage And Handling
Other information cold 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, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D+C yellow no. 10, FD+C green no.3
Other
The ADA Council on Scientific Affairs Acceptance of Top Care Spring Mint Antiseptic Mouth Rinse is based on it finding that the product is effective in helping to prevent and reduct gingivitis and plaque above the gumline, when used as directed.This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of ListerineDSP-TN-15000, DSP-MO-34, SDS-TN-15012
Adverse Reactions
DISTRIBUTED BY TOPCO ASSOCIATES LLC7711 GROSS POINT ROAD, SKOKIE, IL 60077QUESTIONS? 1-888-423-0139 [email protected]
Package Label.Principal Display Panel
Sealed With Printed Neckband For Your ProtectionTopCareSPRING MINTAntisepticMouthRinseADAAcceptedAmericanDentalAssociationKills Germs that CauseBad Breath,Plaque, + theGum DiseaseGingivitisCOMPARE TO LISTERINEactive ingredients1.5 LITERS (50.7 FL OZ)
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