Antiseptic Mouthrinse Mouthwash
FDA Label NDC 49035-072

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc. for the product Antiseptic Mouthrinse (NDC 49035-072). 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

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

Ada Council Statement

"The ADA Council on Scientific Affairs'  Acceptance of Equate Spring Mint Antiseptic Mouthrinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gum Line, when used as directed."

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.

Adverse Reactions Section

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 FreshBurst Listerine

Principal Display Panel

equate

Compare to FreshBurst

Listerine

Active

Ingredients

Antiseptic

Mouthrinse

Kills Germs that Cause:

  • Plaque
  • Gingivitis
  • Bad breath

    • ADA

    Accepted

    American Dental Association

    Spring Mint

    Made in the

    USA

    with 90% OR MORE US PARTS

    Factory Certified

    1.5 LITERS (50.7 FL OZ)

    Image Description (Mm3)

    Image Description (Mm3)

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