Active Ingredients
CALCIUM CARBONATE 10.30%
ALCLOXA 0.05%
Aminocaproic Acid 0.05%
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 0.30%
Rootsallo Toothpaste
FDA Label NDC 82450-050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rootsallo Qwell for the product Rootsallo Toothpaste (NDC 82450-050). 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 ingredients, purpose, uses, warnings, keep out of reach of children, directions, other information, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti plaque, Anti cavities, Healthy Gums, Prevent Gingivitis and Perioodontitis, Prevent Periodontal Disease
Uses
Antiplaque, Anticavity, Healthy Gums Toothpaste
Warnings
(1) Do not swallow, gargle fully after using.
(2) If the use of this paste causes gingiva or oral cavity injury, please stop using and consult a doctor or a dentist.
(3) If childern under 6 years of age use, please apply a pea-sized amount each thime.
Do not swallow. Please use under the guidance of the guardian.
(4) If children under 6 years of age accidentally ingest large amounts of the paste, please consult a doctor or a dentist immediately.
(5) Keep out of reach of children under 6 years of age.
(6) This product contains sodium benzoate, which has mild irritation to the skin, eyes and mucosa.
Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
Directions
Brushing the teeth with a suitable amount
Other Information
Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.
Questions
www.rootsallo.com 82-31-429-0588
Inactive Ingredients
D-Sorbitol Solution, Glycerin, Silica, Xanthan Gum, Carboxymethylcellulose Sodium, Sodium Lauryl Sulfate, Grapefruit Seed Extract, Saccharin Sodium Hydrate, Xylitol, L-Menthol, Green Tea Extract, Propolis Extract, Chitosan, Phytoncide Flavor, Chamaecyparis Obtusa Oil, Water
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