Orajel Kids Superman Toothpaste

SPL v1

SPL

SPL Set ID 2b47af33-32d4-7c06-e063-6394a90a2f33

Route

DENTAL

Published

Effective Date 2025-01-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.5 mg)

Inactive Ingredients

Cellulose Gum Hydrated Silica Stevia Rebaudiana Leaf Sorbitol Water Glycerin Cocamidopropyl Betaine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-07

Description

Sodium fluoride (0.24%) (0.15% w/v fluoride ion)

Medication Information

Indications and Usage

aids in the prevention of dental decay

Dosage and Administration

■ twist off cap and remove foil seal ■ do not swallow ■ supervise children as necessary until capable of using without supervision

adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing)

children under 2 yeras: ask a dentist or physician

Description

Sodium fluoride (0.24%) (0.15% w/v 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

sorbitol, water, hydrated silica, glycerin, cellulose gum, cocamidopropyl betaine, natural flavor, Stevia rebaudiana leaf extract

Section 51945-4

DC STUDIOS

SUPERMAN

STAGE 3 2-10 YEARS

Oraje ^lTM Kids

anti-cavity

TOOTHPASTE

fluoride

NATURAL WATERMELON flavor

NET WT 4.2 OZ (119 g)

Section 55105-1

Anticavity

Section 55106-9

Sodium fluoride (0.24%)

(0.15% w/v fluoride ion)

Structured Label Content

Indications and Usage (34067-9)

aids in the prevention of dental decay

Dosage and Administration (34068-7)

■ twist off cap and remove foil seal ■ do not swallow ■ supervise children as necessary until capable of using without supervision

adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing)

children under 2 yeras: ask a dentist or physician

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)

sorbitol, water, hydrated silica, glycerin, cellulose gum, cocamidopropyl betaine, natural flavor, Stevia rebaudiana leaf extract

Section 51945-4 (51945-4)

DC STUDIOS

SUPERMAN

STAGE 3 2-10 YEARS

Oraje ^lTM Kids

anti-cavity

TOOTHPASTE

fluoride

NATURAL WATERMELON flavor

NET WT 4.2 OZ (119 g)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium fluoride (0.24%)

(0.15% w/v fluoride ion)

Advanced Ingredient Data

[{"name": "CELLULOSE GUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEVIA REBAUDIANA LEAF", "unii": "6TC6NN0876", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "aids in the prevention of dental decay", "34068-7": "■ twist off cap and remove foil seal ■ do not swallow ■ supervise children as necessary until capable of using without supervision adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 yeras: ask a dentist or physician", "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": "sorbitol, water, hydrated silica, glycerin, cellulose gum, cocamidopropyl betaine, natural flavor, Stevia rebaudiana leaf extract", "51945-4": "DC STUDIOS SUPERMAN STAGE 3 2-10 YEARS Oraje lTM Kids anti-cavity TOOTHPASTE fluoride NATURAL WATERMELON flavor NET WT 4.2 OZ (119 g)", "55105-1": "Anticavity", "55106-9": "Sodium fluoride (0.24%) (0.15% w/v fluoride ion)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:17.282993 · Updated: 2026-03-14T23:06:51.816479