Otc - Active Ingredient
Active ingredient(s)
Sodium Fluoride 0.22% (0.10% w/w fluoride ion)
Botalab Herbal Complete Tooth Paste, Dentifrice
FDA Label NDC 50555-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kmpharmaceutical Co., Ltd. for the product Botalab Herbal Complete Tooth (NDC 50555-201). 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, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Anticavity
Indications & Usage
Use(s)
■ Helps prevent cavities
Warnings
Warnings
■ Keep out of reach of children under 6 years of age.
■ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
■ If irritation of the mouth or gums occurs, discontinue use and consult a dentist or physician.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age
Dosage & Administration
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 a dentist or physician.
■ Children 2 to 6 years: Use only a pea-sized amount and supervise brushing to minimize swallowing.
■ Children under 2 years: Ask a dentist or physician.
Other Safety Information
Other Information
■ This product contains 1,000 ppm fluoride.
■ Store at 20°–25°C (68°–77°F).
Otc - Questions
Questions
+1-949-541-9431
riman.com
Inactive Ingredient
Inactive ingredients
Sorbitol, Water, Silica, Glycerin, Xylitol, Sodium Cocoyl Glutamate, Flavor, 2,3-Butanediol, Cellulose Gum, Lauramidopropyl Betaine, Stevia Rebaudiana Extract, Sodium Bicarbonate, Menthol, Sodium Chloride, p-Cymene, Butylene Glycol, Aloe Barbadensis Leaf Extract, Maltodextrin, Asiaticoside, Madecassic Acid, Asiatic Acid, Papain, Centella Asiatica Extract, Alcohol, Camellia Sinensis Leaf Extract, Eugenia Caryophyllus (Clove) Bud Oil, Salvia Officinalis (Sage) Extract, Daucus Carota Sativa (Carrot) Root Extract, Sodium Metabisulfite, Commiphora Myrrha Resin Extract, Potassium Sorbate, Nelumbo Nucifera Flower Extract, Prunus Mume Fruit Extract, Dextrin, Citric Acid, Lactic Acid
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