Mouth Rinse Mouthwash
FDA Label NDC 55910-318

Full FDA labeling including 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 Mouth Rinse (NDC 55910-318). 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 ingredient, 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.

Active Ingredient

 Eucalyptol 0.092%, Menthol 0.042%
Methyl salicylate 0.060%, Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

for is 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 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

Other Information

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

Inactive Ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Tep

Sealed With Printed Neckband For Your Protection

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine Antiseptic Mothwash

Adverse Reactions

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Quality Guaranteed

If you're not satisfied wit this product for any reason, please call us so we can make ou 100% satisfied.
(888)309-9030

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Compare to Original Listerine

Antiseptic Mouthwash

ANTISEPTIC

MOUTHWASH

Antigingivitis/Antiplaque

AMBER

Kills germs that cause bad breath, plaque, and the gum disease gingivitis

500 mL (16.9 FL OZ)

Image Description (Mm1)

Image Description (Mm1)

Since 1903

Rexall

Amber

Antiseptic

Mouthwash

Antigingivitis/Antiplaque

  • Kills 99.9% of germs commonly associated with gingivitis
  • Fights bad breath
  • Helps reduce plaque
  • 1.5 L (1 QT 1 PT 2.7 FL OZ) 50.7 FL OZ

    Image Description (Mm3)

    Image Description (Mm3)

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