Antispetic Mouthwash
FDA Label NDC 49035-664

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 Antispetic (NDC 49035-664). 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.

Label Section Quick Index

Tep

Sealed with printed neckband for your protection

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Use

help 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 unmder 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 atiseptic properties 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 benzoate, FD&C green no.3

Ada Council Statement

"The ADA Council on Scientific Affairs' Acceptance of Equate Blue 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

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

Adverse Reactions

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

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

Principal Display Panel

equate

Compare

to Cool Mint

Listerine

Active

Ingredients

Antiseptic

Mouthrinse

Kills Germs that Cause:

  • Plaque
  • Gingivitis
  • Bad breath

    • ADA

    Accepted

    American

    Dental

    Association

    Blue Mint

    1.5 LITERS (50.7 FL OZ)

    Image Description (Mm3)

    Image Description (Mm3)

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