Otc - Active Ingredient
Active Ingredients
Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%
Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 50804-072
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Perrigo Direct, Inc� for the product Antiseptic Mouth Rinse (NDC 50804-072). 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
Purpose
Antigingivitis, 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
Directions
Adults 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 swallow
Children 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. 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 Listerine
DISTRIBUTED BY:
Geiss, Destin & Dunn, Inc.
385 Highway 74 South
Peachtree City, GA 30269
www.valuelabels.com
DSP-TN-15000
DSP-MO-34
SDS-TN-15012
Package Label.Principal Display Panel
Sealed With Printed Neckband For your Protection
*Compare to the Active Ingredients in Listerine
Good Sense
ANTISEPTIC MOUTH RINSE
Spring Mint
Kills germs that cause bad breath, plaque & the gum disease gingivitis
1 LITER (33.8 FL OZ)
Image Of Principal Display Panel (Mm01)
* Please review the disclaimer below.
