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 Perrigo Direct, Inc.. 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 Ingredients
Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%
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)
* Please review the disclaimer below.
