OTC Labels

Over the Counter Medications

OTC Medication Information: O BlancTis

By Nibec Co., Ltd | Last revised: 7 February 2012

O BLANCTIS — 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.

active ingredient: anhydrous ethyl alcohol
polyvinyl pyrrolidone (K=90), glycerin, distilled water, carbamide peroxide, L-menthol, lemon oil, xylitol, propolis
tooth whitening
keep out of reach of the children
– use twice or three times a day for 2 weeks
- apply a small amount gel on the surface of the teeth in a circular motion and dry for a minute. do not rinse
- do not use on patient with sensitive to hydrogen peroxide, alcohol
- use allowed volue of gel and keep application method
- stop using and ask a doctor if hypersensitivity symptom continue
- keep away from the reach of children
- avoid storage under direct sunlight or high temperature
– you can drink and eat after 20 minutes
package label
(click image for full-size original)
O BLANCTIS
alcohol gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47649-6001
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 50 g in 100 g
Inactive Ingredients
Ingredient Name Strength
POVIDONE K90
glycerin
water
hydrogen peroxide
LEVOMENTHOL
xylitol
LEMON OIL
PROPOLIS WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47649-6001-2 3 TUBE (TUBE) in 1 BOX contains a TUBE (47649-6001-1)
1 NDC:47649-6001-1 5 g in 1 TUBE This package is contained within the BOX (47649-6001-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/07/2012
Labeler — Nibec Co., Ltd (687796909)
Registrant — Nibec Co., Ltd (687796909)
Establishment
Name Address ID/FEI Operations
Nibec Co., Ltd 687796909 manufacture

Revised: 02/2012 Nibec Co., Ltd

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