Act Kids Anticavity Fluoride Rinse Pineapple Punch

Act Kids Anticavity Fluoride Rinse Pineapple Punch
SPL v5
SPL
SPL Set ID 2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b
Route
TOPICAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

ACT ® Kids Anticavity Fluoride Rinse   Pineapple Punch Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

ACT ® Kids Anticavity Fluoride Rinse   Pineapple Punch Drug Facts

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

ACT ® Kids Anticavity

Fluoride Rinse   Pineapple Punch

Drug Facts

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

  • pour out. Only the correct 10 milliliters dose will pour out.

  • 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

benzyl alcohol, blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water

Principal Display Panel

ACT

KIDS

ANTICAVITY

FLUORIDE RINSE

PiNEAPPLE

PUNCH

16.9 fl oz (500 mL)

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a right away.


Structured Label Content

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

ACT ® Kids Anticavity

Fluoride Rinse   Pineapple Punch

Drug Facts

Purpose

Anticavity

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

  • pour out. Only the correct 10 milliliters dose will pour out.

  • 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)

benzyl alcohol, blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ACT

KIDS

ANTICAVITY

FLUORIDE RINSE

PiNEAPPLE

PUNCH

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 accidentally swallowed, get medical help or contact a right away.


Advanced Ingredient Data


Raw Label Data

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