Rembrandt
FDA Label NDC 70108-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ashtel Studios, Inc for the product Rembrandt (NDC 70108-031). 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 drug facts, otc - active ingredient, otc - purpose, indications & usage, otc - keep out of reach of children, dosage & administration, inactive ingredient, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient: Sodium Monofluorophosphate 0.76%
Otc - Purpose
Purpose: Anticavity
Indications & Usage
Use: Aids in the prevention of dental cavities.
Otc - Keep Out Of Reach Of Children
Warnings: Keep out of reach of children under 6 years of age. If more than amount used for brushing is accidentally swallowed,
seek medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions: Adults and children 2 years of age & older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. Children under 6 years of age: Use a pea-sized amount and instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor. Do not swallow.
Inactive Ingredient
Inactive ingredients: CALCIUM CARBONATE, SORBITOL, TREATED WATER, SILICA, SODIUM LAURYL SULPHATE, FLAVOR, SODIUM CARBOXY METHYL CELLULOSE, SODIUM SILICATE, TETRA SODIUM PYROPHOSPHATE, BENZYL ALCOHOL, SODIUM SACCHARIN, PROPYLPARABEN.
Packaging
Image Description (Label1)
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