Act Total Care Anticavity Fluoride Rinse Fresh Mint

Act Total Care Anticavity Fluoride Rinse Fresh Mint
SPL v9
SPL
SPL Set ID 4ee6a478-afcf-4540-b427-ba08c942ccb3
Route
TOPICAL
Published
Effective Date 2024-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Fd&c Blue No. 1 Edetate Calcium Disodium Anhydrous Cetylpyridinium Chloride Menthol Methyl Salicylate Polysorbate 20 Potassium Sorbate Propylene Glycol Sodium Benzoate Sodium Phosphate Saccharin Sodium Fd&c Yellow No. 5 Water Sorbitol Poloxamer 407

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-02-01 Until 2016-01-21

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use
  • aids in the prevention of dental cavities
Section 42229-5

Drug Facts

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

Active Ingredient

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

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, menthol, methyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, blue 1, yellow 5

Learn more at www. ACTFLUORIDE.com

Principal Display Panel

FOR STRONGER

HEALTHIER TEETH

#1 DENTIST RECOMMENDED

BRAND FOR STRENGTHENING ENAMEL

ACT

TOTAL CARE

ANTICAVITY FLUORIDE MOUTHWASH

FRESH MINT

ZERO ALCOHOL

18 fl oz (532 mL)

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.


Structured Label Content

Use
  • aids in the prevention of dental cavities
Section 42229-5 (42229-5)

Drug Facts

Purpose

Anticavity

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

Active Ingredient (Active ingredient)

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Other Information (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 (Inactive ingredients)

water, sorbitol, poloxamer 407, propylene glycol, menthol, methyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, blue 1, yellow 5

Learn more at www. ACTFLUORIDE.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

FOR STRONGER

HEALTHIER TEETH

#1 DENTIST RECOMMENDED

BRAND FOR STRENGTHENING ENAMEL

ACT

TOTAL CARE

ANTICAVITY FLUORIDE MOUTHWASH

FRESH MINT

ZERO ALCOHOL

18 fl oz (532 mL)

Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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