Antiseptic Mouthrinse Mouthwash
FDA Label NDC 72476-072

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Adusa Distribution, Llc for the product Antiseptic Mouthrinse (NDC 72476-072). 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 tep, active ingredients, purpose, use, warnings, do not use if, stop use and ask a dentist if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Tep

→ Active Ingredients

→ Purpose

→ Use

→ Warnings

→ Do Not Use If

→ Stop Use And Ask A Dentist If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Disclaimer

→ Adverse Reaction

→ Principal Display Panel

Tep

Sealed With Printed Neckband For Your Protection

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl sailcylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Use

Helps control plaque that leads to gingivitis

Warnings

For this product

Do Not Use If

you have painful or swollen gums, pus from the gum line, loose teeth or incresed 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 rednss 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 under 12 years if 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 propeties are not affected. Store at room temperature (59° -77° F)

Inactive Ingredients

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

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of FreshBurst ^®Listerine ^{Antiseptic Mouthwash.}