Act Total Care Dry Mouth Anticavity Mouth Rinse
FDA Label NDC 41167-0968

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 Total Care Dry Mouth Anticavity Mouth (NDC 41167-0968). 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 (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

  • do not use if safety seal is broken or missing

Inactive Ingredients

water, glycerin, sorbitol, xylitol, poloxamer 407, betaine, propylene glycol, flavors, bisabolol, carnosine, PEG-14M, PEG-160M, zingiber officinale (ginger) root extract, angelica polymorpha sinensis root extract, lonicera japonica (honeysuckle) flower extract, pueraria lobata root extract, sodium benzoate, potassium sorbate, sodium phosphate, disodium phosphate, polysorbate 20, lactic acid, calcium disodium EDTA, cetylpyridinium chloride, sucralose, green 3, yellow 10 (309-043)

Learn more at www.ACTFLUORIDE.com

Principal Display Panel

#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT® TOTAL CARE
ANTICAVITY FLUORIDE RINSE
DRY MOUTH
● SOOTHES Dry Mouth
● MOISTURIZES Mouth Tissue
● STRENGTHENS Teeth
● FRESHENS Breath
Sodium Fluoride 0.02%
18 fl oz (532 mL)

Principal Display Panel#1 Dentist Recommended Fluoride Brandact® Total Care Anticavity Fluoride Rinse Dry Mouth● Soothes Dry Mouth● Moisturizes Mouth Tissue● Strengthens Teeth● Freshens Breathsodium Fluoride 0.02%18 Fl Oz (532 mL) (Act Total Care Anticavity Fluoride Rinse Dry Mouth 01)

Principal Display Panel#1 Dentist Recommended Fluoride Brandact® Total Care Anticavity Fluoride Rinse Dry Mouth● Soothes Dry Mouth● Moisturizes Mouth Tissue● Strengthens Teeth● Freshens Breathsodium Fluoride 0.02%18 Fl Oz (532 mL) (Act Total Care Anticavity Fluoride Rinse Dry Mouth 01)

Principal Display Panel#1 Dentist Recommended Fluoride Brandact® Total Care Anticavity Fluoride Rinse Dry Mouth● Soothes Dry Mouth● Moisturizes Mouth Tissue● Strengthens Teeth● Freshens Breathsodium Fluoride 0.02%18 Fl Oz (532 mL) (Act Total Care Anticavity Fluoride Rinse Dry Mouth 02)

Principal Display Panel#1 Dentist Recommended Fluoride Brandact® Total Care Anticavity Fluoride Rinse Dry Mouth● Soothes Dry Mouth● Moisturizes Mouth Tissue● Strengthens Teeth● Freshens Breathsodium Fluoride 0.02%18 Fl Oz (532 mL) (Act Total Care Anticavity Fluoride Rinse Dry Mouth 02)

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