Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 0363-0072

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Antiseptic Mouth Rinse (NDC 0363-0072). 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

Active Ingredients

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

Warnings

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.

Of 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 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.  It antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

Inactive Ingredients

water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D+C yellow no. 10, FD+C green no.3

Other

The ADA Council on Scientific  Affairs Acceptance of  Wallgreens 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 Fresh Burst

DSP-TN-1500  DSP-MO-34  SDS-TN-15012

Principal Display Panel

WELL at Walgreens

ANTISEPTIC Mouth Rinse

  • Freshens breath
  • Improves oral hygiene
  • Alcohol 21.6%

    • ADA Accepted American Dental Association

    Spring Mint

    Compare to Listerine Fresh Burst Active ingredients

    16.9 FL OZ (500 mL)

    072.002/072AL

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