Act Total Care Anticavity Fluoride Rinse Dry Mouth

Act Total Care Anticavity Fluoride Rinse Dry Mouth
SPL v12
SPL
SPL Set ID 06684b82-aaa0-4ca6-8d56-4f9866269000
Route
TOPICAL
Published
Effective Date 2024-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.09 mg)
Inactive Ingredients
Water Glycerin Sorbitol Xylitol Poloxamer 407 Betaine Propylene Glycol Levomenol Carnosine Polyethylene Oxide 600000 Polyethylene Oxide 7000000 Ginger Angelica Sinensis Root Lonicera Japonica Flower Pueraria Montana Var. Chinensis Root Sodium Benzoate Potassium Sorbate Sodium Phosphate Disodium Phosphate Polysorbate 20 Lactic Acid Edetate Calcium Disodium Anhydrous Cetylpyridinium Chloride Sucralose Fd&c Green No. 3 D&c Yellow No. 10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-02-01

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
  • 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)

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)
  • do not use if safety seal is broken or missing
Inactive Ingredients (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 (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)

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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