Act Restoring Anticavity Fluoride Cool Mint Mouthwash
FDA Label NDC 41167-0981

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 Cool Mint (NDC 41167-0981). 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 0.02% (0.009% 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 twice a day after brushing your teeth with a toothpaste
  • remove cap
  • pour 10 milliliters into cap (10 mL is equal to 2 teaspoonfuls); do not use more than 10 milliliters
  • 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

  • do not use if safety seal is broken or missing

Inactive Ingredients

water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1 (245-172)

www.actfluoride.com

Principal Display Panel

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
RESTORING
Anticavity Fluoride Mouthwash
Cool Mint
33.8 fl oz. (1 L)

Principal Display Panel#1 Dentist Recommendedfluoride Brandrestoringanticavity Fluoride Mouthwashcool Mint33.8 Fl Oz. (1 L) (Act Restoring Anticavity Fluoride Mouthwash Cool M 01)

Principal Display Panel#1 Dentist Recommendedfluoride Brandrestoringanticavity Fluoride Mouthwashcool Mint33.8 Fl Oz. (1 L) (Act Restoring Anticavity Fluoride Mouthwash Cool M 01)

Principal Display Panel#1 Dentist Recommendedfluoride Brandrestoringanticavity Fluoride Mouthwashcool Mint33.8 Fl Oz. (1 L) (Act Restoring Anticavity Fluoride Mouthwash Cool M 02)

Principal Display Panel#1 Dentist Recommendedfluoride Brandrestoringanticavity Fluoride Mouthwashcool Mint33.8 Fl Oz. (1 L) (Act Restoring Anticavity Fluoride Mouthwash Cool M 02)

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