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Drug Facts
Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558
Listerine Freshburst Antiseptic Mouthwash
FDA Label NDC 69968-0792
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 69968-0792). 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, ask a dentist, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purposes |
|---|---|
| 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
Ask A Dentist
Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use
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
- this rinse is not intended to replace brushing or flossing
- 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 - 1500 Ml Bottle Label
ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH
LISTERINE ®
FRESHBURST ®
ANTISEPTIC
FOR A FRESHER &
CLEANER MOUTH THAN
BRUSHING ALONE
ADA
Accepted
American
Dental
Association ®
1.5 L (1 Qt 1 Pt 2.7 Fl Oz)
Listerine_01 (Listerine 01)
* Please review the disclaimer below.
