Act Anticavity Fluoride Mouthwash Arctic Blast

Act Anticavity Fluoride Mouthwash Arctic Blast
SPL v4
SPL
SPL Set ID 2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c57
Route
TOPICAL
Published
Effective Date 2024-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-02

Description

ACT ® Anticavity™ Fluoride Rinse Arctic Blast Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

ACT ® Anticavity™ Fluoride Rinse Arctic Blast Drug Facts

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

ACT ® Anticavity™ Fluoride Rinse

Arctic Blast

Drug Facts

Principal

ZERO ALCOHOL

ACT

1X Daily

ANTICAVITY

ARCTIC BLAST

18 fl oz (532 mL)

 

Directions

adults 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

children under 6 years of age: consult a dentist or doctor

Active Ingredient

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

Other Information
  • 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

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)

ACT ® Anticavity™ Fluoride Rinse

Arctic Blast

Drug Facts

Purpose

Anticavity

Principal (PRINCIPAL)

ZERO ALCOHOL

ACT

1X Daily

ANTICAVITY

ARCTIC BLAST

18 fl oz (532 mL)

 

Directions

adults 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

children under 6 years of age: consult a dentist or doctor

Active Ingredient (Active ingredient)

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

Other Information (Other information)
  • 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

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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