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Drug Facts
Bright Smiles
FDA Label NDC 71074-109
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Brooke Supplies for the product Bright Smiles (NDC 71074-109). 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, otc - keep out of reach of children, directions, inactive ingredients, principal display panel - 42 g tube label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Fluoride 0.22%
(0.1% w/v fluoride ion)
Purpose
Anticavity toothpaste
Use
aids in the prevention of dental cavities
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- do not swallow
- supervise children as necessary until capable of using without supervision
- Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
- Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
- Children under 2 years of age: Consult a dentist doctor.
Inactive Ingredients
sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharin, sodium methyl paraben, sodium propyl paraben.
Principal Display Panel - 42 G Tube Label
BrightSmiles
Fluoride Gel Toothpaste
NET WT. 1.5 oz (42g)
Principal Display Panel (42 g Tube Label)
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