ORAJEL SUPERMARIO- anticavity toothpaste paste, dentifrice

Orajel SuperMario by

Drug Labeling and Warnings

Orajel SuperMario by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Anticavity

USE

aids in the prevention of dental decay

WARNING

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.

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

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)".

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

ORAJEL SUPERMARIO 
anticavity toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-733
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
STEVIA REBAUDIANA LEAF/STEM EXTRACT (UNII: 6TC6NN0876)
CELLULOSE GUM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-733-42	119 g in 1 TUBE; Type 0: Not a Combination Product	09/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	09/13/2023

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-733)