Act Restoring Anticavity Fluoride Mint Burst Mouthwash
FDA Label NDC 41167-0979

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Act Restoring Anticavity Fluoride Mint Burst (NDC 41167-0979). 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, keep out of reach of children., directions, other information, inactive ingredients, principal display panel, 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

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 once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above 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

  • contains FD&C yellow no. 5 (tartrazine) as a color additive
  • do not use if safety seal is broken or missing

Inactive Ingredients

water, sorbitol, poloxamer 407, propylene glycol, sodium phosphate, polysorbate 20, sodium saccharin, sucralose, disodium phosphate, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, potassium sorbate, flavor, yellow 5, green 3 (309-166)

Principal Display Panel

ZERO ALCOHOL
ACT
1X Daily
RESTORING 
ANTICAVITY FLUORIDE MOUTHWASH
MINT BURST
18 fl oz (532 mL)

Zero Alcoholact1x Dailyrestoring Anticavity Fluoride Mouthwashmint Burst18 Fl Oz (532 mL) (Act Restoring Mint Burst 01)

Zero Alcoholact1x Dailyrestoring Anticavity Fluoride Mouthwashmint Burst18 Fl Oz (532 mL) (Act Restoring Mint Burst 01)

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