Assured Kids Anticavity Fluoride Rinse Bubblegum

Assured Kids Anticavity Fluoride Rinse Bubblegum
SPL v3
SPL
SPL Set ID 8802c26b-47e2-cb92-e053-2995a90a63da
Route
ORAL
Published
Effective Date 2019-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.05 g)
Inactive Ingredients
Sodium Phosphate Benzyl Alcohol Edetate Calcium Disodium Anhydrous Cetylpyridinium Chloride Poloxamer 407 Polysorbate 80 Propylene Glycol D&c Red No. 33 Sodium Benzoate Sodium Phosphate Dibasic Dihydrate Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-06-01
Description

Drug Facts

Medication Information

Warnings and Precautions

Warning

Indications and Usage

Use aids in the prevention of dental cavities.

Dosage and Administration

Directions

  • adults and children 6 years of age and older, use once a day after brushing your teeth with a toothpaste
  • remove cap
  • use approximately one tablespoon and rinse vigorously 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
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Inactive ingredients Benzyl Alcohol, Calcium disodium EDTA, Cetylpyridinium Chloride, Disodium Phosphate, Flavor, Poloxamer 407, Polysorbate 80, Propylene Glycol, Red 33, Sodium Benzoate, Sodium Phosphate, Sodium Saccharin, Sorbitol, Water

Section 51945-4

ASSURED™

Compare to ACT® active ingredient*

Kids Anticavity

Fluoride Rinse

BUBBLEGUM

ALCOHOL FREE

CAVITY PROTECTION

18 FL. OZ. (532 mL)

Section 55105-1

Purpose

Anticavity rinse

Section 55106-9

Active Ingredients

Sodium fluoride 0.05% (Fluoride ion-0.0226%)

Structured Label Content

Indications and Usage (34067-9)

Use aids in the prevention of dental cavities.

Dosage and Administration (34068-7)

Directions

  • adults and children 6 years of age and older, use once a day after brushing your teeth with a toothpaste
  • remove cap
  • use approximately one tablespoon and rinse vigorously 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
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor
Warnings and Precautions (34071-1)

Warning

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive ingredients Benzyl Alcohol, Calcium disodium EDTA, Cetylpyridinium Chloride, Disodium Phosphate, Flavor, Poloxamer 407, Polysorbate 80, Propylene Glycol, Red 33, Sodium Benzoate, Sodium Phosphate, Sodium Saccharin, Sorbitol, Water

Section 51945-4 (51945-4)

ASSURED™

Compare to ACT® active ingredient*

Kids Anticavity

Fluoride Rinse

BUBBLEGUM

ALCOHOL FREE

CAVITY PROTECTION

18 FL. OZ. (532 mL)

Section 55105-1 (55105-1)

Purpose

Anticavity rinse

Section 55106-9 (55106-9)

Active Ingredients

Sodium fluoride 0.05% (Fluoride ion-0.0226%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:39.902767 · Updated: 2026-03-14T22:59:45.666904