Label: DENPO CAVITY PREVENTION- fluoride tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 52146-1001-1 - Packager: Suheung Capsule Co., Ltd
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated March 18, 2010
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredient: Sodium Fluoride
Benefits / Effects
(1) cavity prevention
(2) removal of bad breath, cleaning of oral cavity
Directions / dosage
(1) direction
take and chew one tablet, and clean teeth and gums using tongue and lips, rinse out with water
(2) dosage
2~5 times per day
Caution
(1) avoid direct sunlight, store in a cool dry place
(2) do not swallow
Warning
(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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENPO CAVITY PREVENTION
fluoride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52146-1001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 1.1 mg Product Characteristics Color pink (white pink) Score no score Shape ROUND (none) Size 14mm Flavor Imprint Code 3;hp;x Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52146-1001-1 60 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/18/2010 Labeler - Suheung Capsule Co., Ltd (687943324)
