DENTI WHOO BLUE TABLETGARGLE- sodium fluoride tablet

DENTI WHOO BLUE TABLETGARGLE by

Drug Labeling and Warnings

DENTI WHOO BLUE TABLETGARGLE by is a Otc medication manufactured, distributed, or labeled by SUN LIFE SCIENCE CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Fluoride

INACTIVE INGREDIENT

Sodium Bicarbonate
Tartaric Acid
Hydroxypropylcellulose
Hydroxypropyl methylcellulose
Silica
Zea Mays (Corn) Starch
Sodium Cocoyl Glutamate
Maltitol
Mannitol
Erythritol
Potassium Acesulfame
Magnessium Stearate
Brilliant Blue
Menthol
Yucca Vera Leaf/Root Extract

fragrance

PURPOSE

Tooth-decay prevention, Odor removal from the mouth and Oral Cleansing

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

USAGE : Put 1 tablet in the mouth and use the tongue and lips to rub the gums, teeth, and tongue, gargle it with water, and rinse it several times

WARNINGS

1) Observe the specified usage capacity.
2) Store in a cool place with no sunlight and less moisture.
3) Avoid swallowing.
4) This product contains 583 ppm of fluorine.
5) This product contains fluorine, so if you swallow a large amount, consult a doctor or dentist
immediately.
6) When used by children under the age of 6, use under the supervision of their guardians to
avoid swallowing.
7) Keep out of reach of children under the age of 6

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTI WHOO BLUE TABLETGARGLE 
sodium fluoride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86157-0014
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.10037 g

Inactive Ingredients
Ingredient Name	Strength
TARTARIC ACID (UNII: W4888I119H)
MALTITOL (UNII: D65DG142WK)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	15mm
Flavor	MENTHOL	Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86157-0014-1	8 in 1 PACKAGE; Type 0: Not a Combination Product	04/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/06/2022

Labeler - SUN LIFE SCIENCE CO LTD (695149648)

Registrant - SUN LIFE SCIENCE CO LTD (695149648)

Establishment
Name	Address	ID/FEI	Business Operations
SUN LIFE SCIENCE CO LTD		695149648	manufacture(86157-0014)