The following Structured Product Label (SPL) was submitted to the FDA by Shantou Mcontinents Trading Co, Ltd for the product Smilecare (NDC 69108-001). 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 inactive ingredient, otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, dosage & administration, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Inactive Ingredients: Dicalcium Phosphate, Water, Sorbitol, Silica, Glycerin,
Sodium Lauryl Sulfate, Flavor, Sodium Carboxymethyl Cellulose, Titanium Dioxide,
Hydroxypropyl Gum, Sodium Saccharine, Sodium Benzoate, Sodium Phosphate
Decahydrate, Limonene, Contains Sodium Monoflourophosphate: 1.0556ppm
Active Ingredient: Sodium Monofluorophosphate 0.080 %
Purpose: Anticavity toothpaste
Keep out of reach of children under 6 yrs.
Do not swallow
Directions: Brush your teeth at least twice a day as directed by dentist.
Anticavity toothpaste
Copy Of Label (Smilecare Label)
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