Anticavity Rinse
FDA Label NDC 30142-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co. for the product Anticavity (NDC 30142-004). 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.

Active Ingredient

Sodium fluoride 0.055% (0.02% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warnings

for this product

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 toothpaste
  • remove cap
  • pour 10 mililiters (10 mL mark on inside of cap); do not fill above thr 10 mL mark
  • vigorously swish 10 mililiters 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, cetylpridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Adverse Reaction

Comments or Questions? 800-632-6900 or www. kroger.com

DISTRIBUTED BY

THE KORGER CO.

CINCINNATI, OH 45202

004.002/004AE

Principal Display Panel

Sealed with printed neckband for your protection

IMPORTANT: read directions for proper use

Kroger

QUALITY GUARANTEED

KIDS

anticavity

fluoride rinse

strong cavity protection

alcohol free

helps strengthen teeth

helps prevent cavitis

16.9 FL OZ (500 mL)

bubblegum

FLAVOR

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Image Description (Mm1)

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