Active Ingredient
Sodium fluoride (0.24%) (0.15% w/v fluoride ion)
Orajel Supermario Paste, Dentifrice
FDA Label NDC 10237-733
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Orajel Supermario (NDC 10237-733). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, otc - keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
aids in the prevention of dental decay
Otc - Keep Out Of Reach Of Children
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)".
Package Label.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)
* Please review the disclaimer below.
