Antiseptic Mouthwash
FDA Label NDC 63941-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Valu Merchandisers Company for the product Antiseptic (NDC 63941-003). 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, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 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 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 (59°-77°F).

Inactive Ingredients

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

Questions

Call 1-888-593-0593

Ada Statement

The ADA Council on Scientific Affairs Acceptance of Best Choice 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.

Disclaimer

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

Adverse Reaction

Proudly Distributed By:

VALU MERCHANDISERS, CO

5000 KANSAS AVE

KANSAS CITY, MO 66106

318.002/318AH

Principal Display Panel

Best

Choice

Sealed With Printed Neckband For Your Protection

COMPARE TO THE ACTIVE INGREDIENTS IN LISTERINE

ANTISEPTIC

Mouth Rinse

ANTIGINGIVITIS/ANTIPLAQUE

ADA

Accepted

American Dental Association

Kills Germs That Cause Bad Breath, Plaque & Gingivitis Gum Disease

1 L (33.8 FL OZ)

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