Alcohol-free Anticavity Liquid
FDA Label NDC 36800-482

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Alcohol-free Anticavity (NDC 36800-482). 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, inactive ingredients, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

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, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute 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, glycerin, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Other

Sealed with printed neckband for your protection

Topcare everyday

  • Helps strengthen enamel
  • Helps prevent cavities
  • Kills bad breath germs
  • Freshens breath

    • This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

    *This product is not manufactured or distributed by Procter + Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride Rinse

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    1-888-423-0139  [email protected] www.topcarebrand.com

    482.001/482AB

Principal Display Panel

Coompare to Crest Pro-Health Advanced Anticavity Fluoride Mouthwash*

Topcare everyday

Alcohol free Fluoride Anticavity Mouthwash

Violet mint

  • Helps strengthen enamel
  • Helps prevent cavities
  • Helps keep mouth feeling clean
  • Kills bad breath germs
  • Freshens breath

    • IMPORTANT: read directions for proper use.

    33.8 FL OZ (1 QT 1.8 FL OZ ) 1 L

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.