Kids Flouride Rinse
FDA Label NDC 55301-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Your Military Exchanges for the product Kids Flouride Rinse (NDC 55301-004). 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 ingredient, purpose, use, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warnings

Warnings

Keep Out Of Reach Of Children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliters (10 mL mark on inside of cap): do not fill above the 10 mL mark
  • vigorously swish 10 milliliters 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

Other Information

  • store at room temperature

Inactive Ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Adverse Reactions

*This is not manufactured or distributed by Chattem, Inc., distributor of Act

SATISFACTION GUARANTEED OR YOUR MONEY BACK
Manufactured for Your Military Exchanges
By: Vi-Jon
8515 Page Ave
St. Louis, MO 83114

004.002/004AE

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Compare to the active ingredient of Act Bubblegum Blowout Anticavity Kids Fluoride Rinse

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KIDS

ANTICAVITY FLUORIDE RINSE

ALCOHOL FREE

  • Strong cavity protection
  • Helps strengthen teeth

    • Freshens Breath
    BUBBLE GUM FLAVOR

    IMPORTANT: read directions for proper use.

    quality value

    18 FL OZ (532 mL)

    Image Description (Mm1)

    Image Description (Mm1)

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