Antiseptic Mouthwash
FDA Label NDC 11673-318

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Antiseptic (NDC 11673-318). 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

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ Stop Use And Ask A Dentist If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Adverse Reaction Section

→ Disclaimer

→ Ada Council Statement

→ Principal Display Panel

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antiginvitis, 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 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 year of age - consult a dentsit 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

Adverse Reaction Section

Distributed by Target Corporation

Minneapolis, MN 55403

Made in U.S.A. with U.S. and foreign components

shop target.com

Guest Services 1-800-910-6874

Disclaimer

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

Ada Council Statement

"The ADA Council on Scientifice Affairs Acceptance of Up & Up 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"