5820086 Target Up&up Kids Watermelon Mint (80-15188)

SPL v2

SPL

SPL Set ID 35bc2e4d-f1c7-438e-e063-6394a90aead0

Route

ORAL

Published

Effective Date 2025-10-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.15 g)

Inactive Ingredients

Sodium Saccharin Sorbitol Peg-12 Fd&c Red No. 40 Glycerin Cellulose Gum Cocamidopropyl Betaine Water Sodium Benzoate Titanium Dioxide Hydrated Silica Mica

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-17

Description

Sodium fluoride 0.243% (0.15% w/v fluoride ion) ......... Anticavity

Medication Information

Warnings and Precautions

Keep out of reach of children 6 years of age.

Indications and Usage

aids in the preventnion of dental cavities

Dosage and Administration

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

instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
supersive children as necessary until capable of using without supervision
children under 2 years of age: Consult a dentist or doctor

Description

Sodium fluoride 0.243% (0.15% w/v fluoride ion) ......... Anticavity

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 Posion Control right away.

Section 51727-6

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 55105-1

Anticavity

Section 55106-9

Sodium fluoride 0.243% (0.15% w/v fluoride ion) ......... Anticavity

Structured Label Content

Indications and Usage (34067-9)

aids in the preventnion of dental 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 per day, or as directed by a dentist or doctor

instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
supersive children as necessary until capable of using without supervision
children under 2 years of age: Consult a dentist or doctor

Warnings and Precautions (34071-1)

Keep out of reach of children 6 years of age.

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 Posion Control right away.

Section 51727-6 (51727-6)

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 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium fluoride 0.243% (0.15% w/v fluoride ion) ......... Anticavity

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SODIUM SACCHARIN", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-12", "unii": "NL4J9F21N9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE GUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICA", "unii": "V8A1AW0880", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "aids in the preventnion of dental cavities", "34068-7": "adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) supersive children as necessary until capable of using without supervision children under 2 years of age: Consult a dentist or doctor", "34071-1": "Keep out of reach of children 6 years of age.", "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 Posion Control right away.", "51727-6": "sorbitol, water, hydrated silica, glycerin, cellulose gum, PEG-12, flavor, sodium benzoate, sodium saccharin, cocamidopropyl betaine, mica, titanium dioxide, red 40", "55105-1": "Anticavity", "55106-9": "Sodium fluoride 0.243% (0.15% w/v fluoride ion) ......... Anticavity"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:43.924938 · Updated: 2026-03-14T23:13:06.603726