Sodium Fluoride Mouthwash
FDA Label NDC 53942-581

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Demoulas Super Markets, Inc for the product Sodium Fluoride (NDC 53942-581). 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 claims, active ingredient, purpose, use, warning, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Claims

Leaves your entire mouth feeling clean while it helps strengthen teeth and prevent tooth decay.

Active Ingredient

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warning

for this product

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 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

Inactive Ingredients

water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

Adverse Reaction

*This  product is not manufactured or distributed by Chattem Inc., distributor of Act Restoring Anticavity Mouthwash Cool Mint

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DSP-TN-21091

DSP-MO-20087

DISTRIBUTED BY 

DEMOULAS SUPER MARKETS, INC.

875 EAST STREET

TEWKSBURY, MA 01876

Principal Panel Display

Sealed With Printed Neckband For Your Proection

MARKET BASKET

"MORE FOR YOUR DOLLAR"

compare to Act Restoring Anticavity Fluoride Mouthwash*

Restoring Anticavity Fluoride Mouthwash

ANTICAVITY MOUTHWASH

Restores enamel

Helps avoid tooth decay

Helps remineralize soft spots

Freshens breath

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 L)

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