DR.WHITISS 15%- carbamide peroxide, sodium fluoride gel, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V), SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

NIBEC Co., Ltd.

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Whitening of discolored teeth 1. Gingival and general oral heath should be confirmed before treatment. 2. Brush your teeth before treatment. 3. Follow your dentist’s instructions on how to load gel into your custom whitening tray. Use no more than 1/3 to 1/2 of the syringe per tray. 4. Insert whitening tray in the mouth over the teeth. Seat the tray firmly agains the teeth. Remove excess gel with clean finger or soft toothbrush.(Rinse twice; do not swallow rinsed gel.) 5. Unless directed otherwise by your dentist, wear Dr.Whitiss 10% for 8-10 hours or overnight, Dr.Whitiss 15% for 4-6 hours, Dr.Whitiss20% for 2-4 hours, and Dr.Whitiss 35% for 30 minutes. 6. If significant sensitivity occurs, stop treatment and consult dentist.

Authorization status:

OTC monograph not final

Summary of Product characteristics

DR.WHITISS 15%- CARBAMIDE PEROXIDE, SODIUM FLUORIDE GEL, DENTIFRICE
NIBEC CO., LTD.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
----------
DRUG FACTS
Carbamide Peroxide 15%
Sodium Fluoride 0.25%
Povidone (K90), Anhydrous Ethanol, Hydroxyethyl Cellulose, Glycerin,
Purified Water,
Monobasic Potassium Phosphate, Sodium Hydroxide, L-Menthol, Potassium
Nitrate
Whitening of discolored teeth
Keep gel out of reach of small children.
1. Gingival and general oral heath should be confirmed before
treatment.
2. Brush your teeth before treatment.
3. Follow your dentist’s instructions on how to load gel into your
custom whitening tray.
Use no more than 1/3 to 1/2 of the syringe per tray.
4. Insert whitening tray in the mouth over the teeth. Seat the tray
firmly agains the
teeth. Remove excess gel with clean finger or soft toothbrush.(Rinse
twice; do not
swallow rinsed gel.)
5. Unless directed otherwise by your dentist, wear Dr.Whitiss 10% for
8-10 hours or
overnight, Dr.Whitiss 15% for 4-6 hours, Dr.Whitiss20% for 2-4 hours,
and Dr.Whitiss
35% for 30 minutes.
6. If significant sensitivity occurs, stop treatment and consult
dentist.
1. Products containing peroxides are not recommended for children
under the age of 18
and pregnant or lactating women.
2. Regular dental checkups and cleanings are important before and
after bleaching to
maintain a healthy smile.
3. Do not use this product if you are allergic to any of the
ingredients.
4. If you have any questions regarding the appropriate use of this
product, including
how long it will take to bleach your teeth, please consult a dentist
as soon as possible.
5. If irritation occurs such as redness, soreness, or swelling of the
gums or mouth,
discontinue use and consult a dental professional or physician.
6. Do not swallow. If a significant amount is swallowed, please call
Poison Control
immediately.
7. Do not use toba