The following Structured Product Label (SPL) was submitted to the FDA by Zion Synthetic Fiber Corporation Limited for the product Escopinio Phyto Alpha Toothpaste (NDC 44781-447). 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 otc - active ingredient, inactive ingredient, otc - when using, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active Ingredients: Sodium Monofluorophosphate
Inactive Ingredient
Other Ingredients:Water, Dicalcium Phosphodihydrate, Tocopheryl Acetate, Sodium Benzoate, d-Sorbitol, Sodium Carboxymethylcellulose, Silica, Monosodium Phosphate, Sodium Lauryl Sulfate, Monooleic Sorbate, Tetrasodium Pyrophosphate, Sodum Saccharin, Xylitol, Mentha (peppermint), Fragrance HF 30302, Sage Oil, Myrrh Extract, Cardamom Extract, Blue FCF #1, Yellow #4, Titanium Dioxide
Otc - When Using
Directions:Adults and children 2 years and older:Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by your dentist.Children under 6 years of age:To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established.Children under 2 years: Ask a dentist or physician
Storage And Handling
Care and Handling:Keep the lid tightly closed after using.Keep at a room temperature
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