Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Eucalyptol, Menthol, Methyl Salicylate, Thymol Mouthwash
FDA Label NDC 75712-881
15 label sections · Submitted to the FDA by Old East Main Co. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Eucalyptol, Menthol, Methyl Salicylate, Thymol (NDC 75712-881). 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 active ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigingivitis, Antiplaque
Use
helps control plaque that leads to gingivitis
Warnings
for this product
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.
Stop Use And Ask A Dentist If
gingivitis, bleeding, or redness persists for more than 2 weeks
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.
Directions
adults and children 12 years of age and older: vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow
children 6 years to under 12 years of age: supervise use
children under 6 years of age: do not use
- this rinse is not intended to replace brushing or flossing
Other Information
cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59° to 77°F).
Inactive Ingredients
water, alcohol (21.6 %), sorbitol, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, flavor, sodium saccharin, Mentha piperita (peppermint) oil, Mentha viridis (spearmint) leaf oil, blue 1
Questions Or Comments?
Call 1-(888) 309-9030
Disclaimer
*This product {or product name} is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ®Gum Therapy Glacier Mint Mouthwash.
Adverse Reactions
DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072
100% Satisfaction Guaranteed!
(888) 309-9030
DSP-TN-21091 DSP-MO-20087
Tamper Evident Statement
Sealed with printed neckband for your protection.
Principal Display Panel
NDC 75712-881-77
Compare to Listerine ®Gum Therapy Glacier Mint Mouthwash*
Since 1903
Rexall™
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Antigingivitis/Antiplaque
Use 2x/Day For Better Oral Hygiene
- Fights Plaque and Gingivitis
- Freshens Breath
16.9 FL OZ (500 mL) 1.05 PT
Image Description (Mm01)
Image Description (Mm02)
* Please review the disclaimer below.
