5820028 Kroger Kids Fluoride Toothpaste Strawberry

SPL v13

SPL

SPL Set ID 82b9db89-d108-3f64-e053-2991aa0aee74

Route

DENTAL

Published

Effective Date 2019-02-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.76 g)

Inactive Ingredients

Glycerin Carrageenan Calcium Carbonate Hydrated Silica Water Sodium Lauroyl Sarcosinate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-02-25

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 thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children 2 to 6 years: use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

Store in a cool dry place. Keep tube covered 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 Glycerin, Water, Calcium Carbonate, Hydrated Silica, Natural Flavor, Carrageenan, Sodium Lauroyl Sarcosinate

Section 51945-4

simple truth

KIDS' Fluoride Toothpaste

PREVENTS CAVITIES

STRAWBERRY

no artificial colors, preservatives, flavors or sweeteners

4.2 OZ (119g)

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

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 thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children 2 to 6 years: use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).

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

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 covered 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 Glycerin, Water, Calcium Carbonate, Hydrated Silica, Natural Flavor, Carrageenan, Sodium Lauroyl Sarcosinate

Section 51945-4 (51945-4)

simple truth

KIDS' Fluoride Toothpaste

PREVENTS CAVITIES

STRAWBERRY

no artificial colors, preservatives, flavors or sweeteners

4.2 OZ (119g)

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARRAGEENAN", "unii": "5C69YCD2YJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "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": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.76", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use Helps protect against cavities", "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. Children 2 to 6 years: use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing). Children under 2 years of age: consult a dentist or physician.", "34071-1": "Warnings", "42229-5": "Drug Facts", "44425-7": "Other information Store in a cool dry place. Keep tube covered 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 Glycerin, Water, Calcium Carbonate, Hydrated Silica, Natural Flavor, Carrageenan, Sodium Lauroyl Sarcosinate", "51945-4": "simple truth KIDS' Fluoride Toothpaste PREVENTS CAVITIES STRAWBERRY no artificial colors, preservatives, flavors or sweeteners 4.2 OZ (119g)", "55105-1": "Purpose Anticavity", "55106-9": "Active ingredient Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:42.360431 · Updated: 2026-03-14T23:11:26.161918