Otc - Active Ingredient
Sodium fluoride (0.24%)
(0.15% w/v fluoride ion)
Orajel Kids Superman Gel, Dentifrice
FDA Label NDC 10237-732
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 Kids Superman (NDC 10237-732). 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 otc - active ingredient, otc - purpose, indications & usage, otc - keep out of reach of children, dosage & administration, inactive ingredient, 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
Otc - Purpose
Anticavity
Indications & Usage
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.
Dosage & 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
Inactive Ingredient
sorbitol, water, hydrated silica, glycerin, cellulose gum, cocamidopropyl betaine, natural flavor, Stevia rebaudiana leaf extract
Package Label.Principal Display Panel
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)
* Please review the disclaimer below.
