5820034 Heb Cavity Protection Watermelon Mint (8015188)

5820034 Heb Cavity Protection Watermelon Mint (8015188)
SPL v9
SPL
SPL Set ID a6af1baf-17bf-428c-8744-1490359b0cfb
Route
DENTAL
Published
Effective Date 2013-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g)
Inactive Ingredients
Mica Glycerin Water Sodium Benzoate Sorbitol Titanium Dioxide Saccharin Sodium Cocamidopropyl Betaine Hydrated Silica Polyethylene Glycol 600 Carboxymethylcellulose Sodium, Unspecified Form Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2012-12-01 Until 2019-02-20
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use Helps protect against cavities

Dosage and Administration

Directions

Adults and children 2 years of age and older:brush teeth thoroughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

  • Do not swallow
  • To minimize swallowing use a pea-sized amount in children under 6
  • Supervise childrens brushing until good habits are established

Children under 2 years of age: consult a dentist or doctor.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

Store in a cool dry place. Keep tube capped when not in use.

Section 50565-1

Keep out of reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients sorbitol, water, hydrated silica, glycerin, cellulose gum, PEG-12, flavor, sodium benzoate, sodium saccharin, cocamidopropyl betaine, mica, titanium dioxide, red 40

Section 51945-4

Section 53413-1

Questions?Call 1-877-777-2743

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active ingredient

Sodium Fluoride 0.243%

Structured Label Content

Indications and Usage (34067-9)

Use Helps protect against cavities

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older:brush teeth thoroughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

  • Do not swallow
  • To minimize swallowing use a pea-sized amount in children under 6
  • Supervise childrens brushing until good habits are established

Children under 2 years of age: consult a dentist or doctor.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

Store in a cool dry place. Keep tube capped when not in use.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients sorbitol, water, hydrated silica, glycerin, cellulose gum, PEG-12, flavor, sodium benzoate, sodium saccharin, cocamidopropyl betaine, mica, titanium dioxide, red 40

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?Call 1-877-777-2743

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium Fluoride 0.243%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:13.173476 · Updated: 2026-03-14T23:10:28.026216