Anticavity Rinse
FDA Label NDC 55910-030

11 label sections · Submitted to the FDA by Old East Main Co. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Anticavity (NDC 55910-030). 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

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, see 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
  • 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 temperture

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

Tamper Evident Statement

Sealed with printed neckband for your protection

Adverse Reaction

Visit us at: Rexall.com or call 1-866-4-REXALL

DISTRIBUTED BY Old East Main CO,

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

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Since 1903

Rexall™

kids

Anticavity

Fluoride Rinse

Anticavitvy Fluoride Rinse

  • Helps prevent cavities
  • Helps strengthen teeth
  • Alcohol free

    • IMPORTANT: read directions for proper use.

    ADA Accepted

    America Dental Association

    Helps Prevent cavities

    Bubblegum Flavor

    500 mL (1.05 PT) 16.9 FL OZ

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