Antiseptic Rinse
FDA Label NDC 49035-318

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc. for the product Antiseptic (NDC 49035-318). 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 tep, active ingredients, purpose, use, warnings, do not use, 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.

Tep

Sealed with printed neckband for your protection

Active Ingredients

Eucalyptol 0.092%, Menthol 0.042% Methy salicylate 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 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 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 wealther 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 Reactions

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the registered mark Original Listerine  ®

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Principal Display Panel

NDC 49035-318-12

equate ™

Compare to Original Listerine ® Active Ingredients*

Antiseptic Mouthrinse

Kills Germs that Cause:

Plaque
Gingivitis
Bad Breath
ADA Accepted American Dental Association

Helps reduct plaque
Helps reduce gingivits
Original

Made in the USA WITH 90% OR MORE US PARTS

Factory Certified

1.5 LITERS (50.7 FL OZ)

Image Description (Mm01)

Image Description (Mm01)

* Please review the disclaimer below.