Orajel Kids Super Mario Anticavity Toothpaste

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (2.4 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-09-13

Medication Information

Purpose

Anticavity

Description

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

Use

aids in the prevention of dental decay

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 51945-4

SUPER MARIO

STAGE 3

2-10 YEARS

ORAJEL ^TM KIDS

anti-cavity

TOOTHPASTE

fluoride

NATURALLY SOURCED*

NATURAL BERRY

NET WT 4.2 OZ (119 g)

Directions

■ twist off cap and remove foil seal ■ do not swallow ■ supervise children as necessary until capable of using wilhout 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 years: ask a dentist or physician

Active Ingredient

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

Inactive Ingredients

Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia), Natural flavor.

All inactive ingredients are described in the format "ingredient name (source)".

Structured Label Content

Use (USE)

aids in the prevention of dental decay

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 51945-4 (51945-4)

SUPER MARIO

STAGE 3

2-10 YEARS

ORAJEL ^TM KIDS

anti-cavity

TOOTHPASTE

fluoride

NATURALLY SOURCED*

NATURAL BERRY

NET WT 4.2 OZ (119 g)

Purpose (PURPOSE)

Anticavity

Directions (DIRECTIONS)

■ twist off cap and remove foil seal ■ do not swallow ■ supervise children as necessary until capable of using wilhout 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 years: ask a dentist or physician

Active Ingredient (ACTIVE INGREDIENT)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia), Natural flavor.

All inactive ingredients are described in the format "ingredient name (source)".

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEVIA REBAUDIANA LEAF", "unii": "6TC6NN0876", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE GUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "2.4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE": "aids in the prevention of dental decay", "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.", "51945-4": "SUPER MARIO STAGE 3 2-10 YEARS ORAJEL TM KIDS anti-cavity TOOTHPASTE fluoride NATURALLY SOURCED* NATURAL BERRY NET WT 4.2 OZ (119 g)", "PURPOSE": "Anticavity", "DIRECTIONS": "■ twist off cap and remove foil seal ■ do not swallow ■ supervise children as necessary until capable of using wilhout 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 years: ask a dentist or physician", "ACTIVE INGREDIENT": "Sodium fluoride (0.24%) (0.15% w/v fluoride ion)", "INACTIVE INGREDIENTS": "Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia), Natural flavor. All inactive ingredients are described in the format "ingredient name (source)"."}

Orajel Kids Super Mario Anticavity Toothpaste

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information