Otc - Active Ingredient
Active ingredient: Sodium Fluoride
Denpo
FDA Label NDC 52146-1001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Suheung Capsule Co., Ltd for the product Denpo (NDC 52146-1001). 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, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description
Benefits / Effects(1) cavity prevention(2) removal of bad breath, cleaning of oral cavityDirections / dosage(1) directiontake and chew one tablet, and clean teeth and gums using tongue and lips, rinse out with water(2) dosage2~5 times per dayCaution(1) avoid direct sunlight, store in a cool dry place(2) do not swallowWarning(1) the fluoride content of this product is 597.46 ppm (total fluoride content needs to be below 1,000 ppm)(2) for children under six, use a pea-sized amount per use, do not eat or swallow(3) immediately contact a physician if a child under six has swallowed a large portion(4) keep and store away from children under six
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