5820011 Heb Kid's Strawberry W/fluroide Tp (80-15276)

SPL v5

SPL

SPL Set ID ab361305-01f9-7379-e053-2995a90a97b4

Route

DENTAL

Published

Effective Date 2020-07-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.13 g)

Inactive Ingredients

Hydrated Silica Calcium Carbonate Water Sodium Lauroyl Sarcosinate Carrageenan Glycerin

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-07-24

Description

Sodium monofluorophosphate 0.76% (0.13% fluoride ion)

Medication Information

Indications and Usage

Helps protect against cavities

Dosage and Administration

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 amoutn in children under 6

* supervise children's brushing until good habits are established

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

Description

Sodium monofluorophosphate 0.76% (0.13% fluoride ion)

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

glycerin, water, calcium carbonate, hydrated silica, natural flavor, carrageenan, sodium lauroyl sarcosinate

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9

Sodium monofluorophosphate 0.76% (0.13% fluoride ion)

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)

Helps protect against cavities

Dosage and Administration (34068-7)

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 amoutn in children under 6

* supervise children's brushing until good habits are established

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

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)

glycerin, water, calcium carbonate, hydrated silica, natural flavor, carrageenan, sodium lauroyl sarcosinate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium monofluorophosphate 0.76% (0.13% fluoride ion)

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

[{"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAUROYL SARCOSINATE", "unii": "632GS99618", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARRAGEENAN", "unii": "5C69YCD2YJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Helps protect against cavities", "34068-7": "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 amoutn in children under 6 * supervise children's brushing until good habits are established Children under 2 years of age: consult a dentist or doctor.", "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": "glycerin, water, calcium carbonate, hydrated silica, natural flavor, carrageenan, sodium lauroyl sarcosinate", "55105-1": "Anticavity", "55106-9": "Sodium monofluorophosphate 0.76% (0.13% fluoride ion)", "60561-8": "Store in a cool, dry place. Keep tube capped when not in use."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:45.374166 · Updated: 2026-03-14T23:13:37.162375