Act Kids Anticavity Fluoride Rinse Watermelon

Act Kids Anticavity Fluoride Rinse Watermelon
SPL v4
SPL
SPL Set ID 8d7faeab-ac70-472a-acbb-de67493718ce
Route
TOPICAL
Published
Effective Date 2024-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.5 mg)
Inactive Ingredients
Edetate Calcium Disodium Anhydrous Cetylpyridinium Chloride Sodium Phosphate, Dibasic, Anhydrous Fd&c Green No. 3 Poloxamer 407 Polysorbate 20 Potassium Sorbate Propylene Glycol Sodium Benzoate Sodium Phosphate Sorbitol Sucralose Water Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-01

Description

ACT® Anticavity Wild Watermelon Fluoride Rinse

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

ACT® Anticavity Wild Watermelon Fluoride Rinse

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

ACT® Anticavity Wild Watermelon

Fluoride Rinse

Active I

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Directions

a dults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste

  • remove cap

  • hold bottle upright and squeeze. Fill to FILL LINE (10 mL)

  • 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

c hildren 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

calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, green 3, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, yellow 5 (309-023)

Principal Display Panel

ACT

Kids

ANTICAVITY

FLUROIDE RINSE

Wild Watermelon

Sugar & Alcohol Free

Sodium Fluoride 0.05%

16.9 fl oz (500 mL)

Keep Out of Reach of Children.

If more than used for rinsing is accidently swallowed, get medical help or contact Poison Control Center right away.


Structured Label Content

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

ACT® Anticavity Wild Watermelon

Fluoride Rinse

Purpose

Anticavity

Active I (Active i)

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Directions

a dults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste

  • remove cap

  • hold bottle upright and squeeze. Fill to FILL LINE (10 mL)

  • 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

c hildren 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 (Inactive ingredients)

calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, green 3, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, yellow 5 (309-023)

Principal Display Panel

ACT

Kids

ANTICAVITY

FLUROIDE RINSE

Wild Watermelon

Sugar & Alcohol Free

Sodium Fluoride 0.05%

16.9 fl oz (500 mL)

Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidently swallowed, get medical help or contact Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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