Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 11344-072

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Antiseptic Mouth Rinse (NDC 11344-072). 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 - Active Ingredient

Active Ingredients   Eucalyptol 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 you 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 ageConsult a dentist or doctorThis rinse is not intended to replace brushing or flossing

Storage And Handling

Other information cold weather may cloud this product.  It antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

Inactive Ingredient

Inactive ingredients water, alcohol 21.6%, sorbitol solution, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D+C yellow, FD+C green no. 3

Other

The ADA Council on Scientific  Affairs Acceptance of Good Sense Spring Mint Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of ListerineDISTRIBUTED BY:Vi-Jon8515 Page AvenueSt. Louis, MO 631141-888-593-0593DSP-TN-15000DSP-MO-34SDS-TN-15012

Package Label.Principal Display Panel

Sealed With Printed Neckband For your ProtectionCompare to the Active Ingredients in ListerineGood Sense  NDC 11344-072-86ANTISEPTICMOUTH RINSEKills Germs that CauseBad Breath, Plaque +The Gum Disease GingivitisADAAcceptedAmericanDental Association1L (33.8 FL OZ)

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