Anticavity Rinse Mouthwash
FDA Label NDC 55319-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Stores, Inc for the product Anticavity Rinse (NDC 55319-004). 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

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 year 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 year 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

Disclaimer

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act® Bubblegum Blow Out® Anticavity Kids Fluoride Rinse.

Adverse Reaction

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PKWY

CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED?

Return within 30 days to the store of purchase for a refund (with receipt) or exchange.

MADE IN THE US WITH US AND FOREIGN COMPONENTS

Principal Display Panel

IMPORTANT: read directions for proper use.

sealed with printed neckband for your protection.

Do not use if band around cap is broken or missing.

FAMILY WELLNESS™

Compare to ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse*

Children's ANTICAVITY FLUORIDE RINSE

  • Strong cavity protection
  • Alcohol free
  • Helps strengthen teeth
  • Helps prevent cavities

    • BUBBLEGUM FLAVOR

    18 FL OZ (1.12 PT) 532 mL

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.