DENPO CAVITY PREVENTION- fluoride tablet, chewable 
Suheung Capsule Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

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

image of box label
DENPO  CAVITY PREVENTION
fluoride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52146-1001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 mg
Product Characteristics
Colorpink (white pink) Scoreno score
ShapeROUND (none) Size14mm
FlavorImprint Code 3;hp;x
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52146-1001-160 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/18/2010
Labeler - Suheung Capsule Co., Ltd (687943324)

Revised: 3/2010
Document Id: aab6ec68-7848-4a67-82dc-6f5b5636eb0f
Set id: 54d94e7c-e62a-473f-b2fa-448396076dee
Version: 1
Effective Time: 20100318
 
Suheung Capsule Co., Ltd