Percara Bubblegum Fluoride Rinse

Percara Bubblegum Fluoride Rinse
SPL v2
SPL
SPL Set ID be3a7272-acfb-7d14-e053-2995a90a9420
Route
ORAL
Published
Effective Date 2021-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-23
Description

Drug Facts

Medication Information

Warnings and Precautions

Warning

Indications and Usage

Uses

aids 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 plycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Section 51945-4

PERCARA™

ALCOHOL FREE

CAVITY PROTECTION

kids BUBBLE GUM

FLUORIDE RINSE

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)

Uses

aids 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 plycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Section 51945-4 (51945-4)

PERCARA™

ALCOHOL FREE

CAVITY PROTECTION

kids BUBBLE GUM

FLUORIDE RINSE

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: 2026-02-15T12:02:41.608559 · Updated: 2026-03-14T23:02:23.126471