FDA Label for Orajel Fluoride
View Indications, Usage & Precautions
Orajel Fluoride Product Label
The following document was submitted to the FDA by the labeler of this product Church & Dwight Co., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Sodium Fluoride (0.24%)
Otc - Purpose
Anticavity Toothpaste
Indications & Usage
Use aids in the prevention of dental decay
Warnings
Keep out of reach of children under 6 years of age.
Otc - Keep Out Of Reach Of Children
If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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 years - ask a dentist or physician
Inactive Ingredient
sorbitol, water, hydrated silica, PEG-8, flavor, cellulose gum, sodium saccharin, sodium lauryl sulfate, blue 1
Otc - Questions
Questions or comments Call us at 800 952 5080 Monday through Friday 9 - 5 ET or visit our website at www orajel com
Package Label.Principal Display Panel
Berry Divine
Orajel ™
Anticavity
Fluoride
Toothpaste
Shimmer and Shine
NET WT. 4.2 OZ (119g)
Nickelodeon
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