5820035 Heb Cavity Protection Bubblegum (8015167)

SPL v6

SPL

SPL Set ID 2c972c65-34aa-4348-b997-c5e65a884575

Route

DENTAL

Published

Effective Date 2025-03-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.15 g)

Inactive Ingredients

Glycerin Water Sodium Benzoate Sorbitol Saccharin Sodium Cocamidopropyl Betaine Hydrated Silica Titanium Dioxide 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

Active ingredient Sodium Fluoride 0.24%

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use Helps protect against caviites

Dosage and Administration

Directions

Adults and children 2 years of age and older:brush teeth thorughly 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

Active ingredient Sodium Fluoride 0.24%

Section 42229-5

MADE WITH PRIDE AND CARE FOR H-E-B,

SAN ANTONIO, TX 78204

MADE IN USA

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

Section 51945-4

Section 53413-1

Questions or Comments?

Call 1-877-777-2743

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active ingredient

Sodium Fluoride 0.24%

Structured Label Content

Indications and Usage (34067-9)

Use Helps protect against caviites

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older:brush teeth thorughly 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)

MADE WITH PRIDE AND CARE FOR H-E-B,

SAN ANTONIO, TX 78204

MADE IN USA

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?

Call 1-877-777-2743

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium Fluoride 0.24%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Use Helps protect against caviites", "34068-7": "Directions Adults and children 2 years of age and older: brush teeth thorughly 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.", "34071-1": "Warnings", "42229-5": "MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204 MADE IN USA", "44425-7": "Other information Store in a cool dry place. Keep tube capped when not in use.", "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.", "51727-6": "Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-12, cellulose gum, flavor, titanium dioxide, sodium benzoate, sodium saccharin, cocamidopropyl betaine, red 40", "53413-1": "Questions or Comments? Call 1-877-777-2743", "55105-1": "Purpose Anticavity", "55106-9": "Active ingredient Sodium Fluoride 0.24%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:42.719055 · Updated: 2026-03-14T23:09:37.690586