Active Ingredient
Active Ingredient: Sodium Monofluorophosphate 0.76%
Esopinio Topaz Phyto
FDA Label NDC 44781-230
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zion Synthetic Fiber Co., Ltd. for the product Esopinio Topaz Phyto (NDC 44781-230). 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 active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications and usage, dosage and administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients:
Dicalcium Phosphodihydrate, Tocopheryl Acetate, Sodium Benzoate, d-Sorbitol, Sodium, Carboxymethylcellulose, Silica, Monosodium Phosphate, Sodium Lauryl Sulfate, Sorbitan, Monooleate, Tetrasodium Phyrophosphate, Sodium Saccharin, Xylitol, Mentha (peppermint)
Leaf Extract, Fragrance, Salvia Officinalis (Sage) Leaf Extract, Commiphora Myrrha Extract, Cardamom Extract, Chamomilla Recutita (Matricaria) Flower Extract, Blue l, Yellow 5, Titanium Dioxide, Composite Topaz (MM-1), Water
Purpose
Purpose:
1. Cavity Protection
2. Anti-plaque
3. Whitens Teeth
4. Breath Freshening
Warnings
Warnings:
If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center iimmediately. Children under 2 years, ask a dentist or physician.
Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
Indications And Usage
Indications and usage:
1. Brush teeth thoroughly, preferably after each meal, or at least twice a day,
2. Keep the lid tightly closed after using.
3. Keep at a room temperature
Dosage And Administration
Dosage and Administration:
1. Children 2 to 6 years of age: To minimize swallowing, use only a pea sized amount and supervise child's brushing until good habits are established.
2. Children under 2 years: Ask your dentist or physician.
3. Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal, or at least twice a day.
* Please review the disclaimer below.
