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Drug Facts
Orajel Gel, Dentifrice
FDA Label NDC 10237-734
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 (NDC 10237-734). 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 other, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride (0.24%)
(0.15% w/v fluoride ion)
Purpose
Anticavity
Use
aids in the prevention of dental decay
Warnings
Warning
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 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 Ingredients
sorbitol, water, hydrated silica, glycerin, cellulose gum, cocamidopropyl betaine, Stevia rebaudiana leaf extract, natural flavor,
Questions Or Comments?
Call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at orajelkids.com
Principal Display Panel
Disney • PIXAR
TOY STORY 5
2-10 YEARS
OrajeL TM naturals
anti-cavity
toothpaste
fluoride
natural watermelon flavor
protects against cavities, helps strengthen enamel and keep gums healthy
NET WT 5.8 OZ (164g)
* Please review the disclaimer below.
