FDA Label for Antiseptic Mouth Rinse
View Indications, Usage & Precautions
Antiseptic Mouth Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid. 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 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 Rite Aid Fresh 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 BYRite Aid30 Hunter Lane, camp Hill, PA 17011Learn more atwww.RiteAid.com
Package Label.Principal Display Panel
RITEAIDPHARMACYcompare to theactive ingredients in Listerineoral careantisepticmouth rinsefresh mintADAAcceptedAmericanDentalAssociationkills germs that cause badbreth, plaque and the gumdisease gingivitis1L (33.8 FL OZ)
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