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Name:Blanctis Essencetooth Whitening Gel
Manufacturer:Nibec Co., Ltd
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BLANCTIS ESSENCE TOOTH WHITENING GEL - alcohol gel, dentifrice 
Nibec 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: Alcohol

1. Name Of Product : BlancTis Essence Gel

2. Caution :
Do not use on patient with sensitive to hydrogen peroxide, alcohol.
Use allowed volume of gel and keep application method.
Stop using and ask a doctor if hypersensitivity symptom continue.
Keep away form the reach of children.
Avoid storing under direct sunlight or high temperature.

3. Ingredient :
Water, Glycerin, Hydrogen Peroxide, Povidone, L-menthol, Xylitol, Spearmint oil

4. Effect:
- Patented Whitening formula guarantees the effect
- Safe and Effective
- Unique rubber application tip allows you to target specific teeth, making the Whitening process customized to your needs.
- Whitening power is activated by NIBEC's Delivery technology.
- BlancTis Essence Gel only takes a minutes to apply.
- Whitening gel is clinically proven to whiten teeth in two weeks.

5. Use:
1. Use twice or three times a day for 2 weeks.
2. Apply the gel on the surface of the teeth in a circular motion and dry for a minute.
3. Do not rinse.
4. You can drink and eat after 20 minutes.

6. Tooth stimulation norm: non irritation

7. Name of Address Of The Manufacturer

NIBEC: Nano Intelligent Biomedical Engineering Corporation
Iwol electricity electronic agro-industrial Complex, 1127, Sinwol-ri, Iwol-myeon, Jincheon-gun, chungchengbuk-do, Korea
TEL : 82-43-532-7458, 82-80-765-1980
FAX : 82-43-537-1714, 82-2-747-9647

8. Preservation condition : room temperature

9. Weight and packaged capacity
  : 3.5g tube 12ea
 
10. Shelf-life : 18 months.

image of carton label

BLANCTIS ESSENCE  TOOTH WHITENING GEL
alcohol gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47649-4001
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 500 mg  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47649-4001-2 12 TUBE ( TUBE) in 1 CARTON contains a TUBE (47649-4001-1)
1 NDC:47649-4001-1 3.5 g in 1 TUBE This package is contained within the CARTON (47649-4001-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/05/2010

Labeler - Nibec Co., Ltd (687796909)

Revised: 03/2010 Nibec Co., Ltd



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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