Listerine Freshburst Antiseptic Mouthwash
FDA Label NDC 69968-0239

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Listerine Freshburst Antiseptic (NDC 69968-0239). 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 other, otc - purpose, uses, otc - do not use, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

Otc - Purpose

Active ingredientsPurposes
Eucalyptol (0.092%)Antiplaque/antigingivitis
Menthol (0.042%)Antiplaque/antigingivitis
Methyl Salicylate (0.060%)Antiplaque/antigingivitis
Thymol (0.064%)Antiplaque/antigingivitis

Uses

helps prevent and reduce:

  • plaque
  • gingivitis

Otc - Do Not Use

Do not use in children under 12 years of age

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.

Directions

  • rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night
  • do not swallow

Other Information

  • Store at room temperature
  • cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive Ingredients

Water, Alcohol (21.6% v/v), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Flavor, Sodium Benzoate, Yellow 10, Green 3

Questions?

Call toll-free 888-222-0182 or 215-273-8755 (Collect)

Principal Display Panel - 1.5 L Bottle Label

ANTISEPTIC
LISTERINE®
FRESHBURST®
FOR A FRESHER &
CLEANER MOUTH THAN
BRUSHING ALONE

ADA
Accepted
American
Dental
Association    ®

1.5 L (1 Qt 1 Pt 2.7 fl oz)

Principal Display Panel (1.5 L Bottle Label)

Principal Display Panel (1.5 L Bottle Label)

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