IODENT SENSITIVE- potassium nitrate,sodium fluoride paste

IODENT SENSITIVE by

Drug Labeling and Warnings

IODENT SENSITIVE by is a Otc medication manufactured, distributed, or labeled by Zhaoqing Longda Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Potassium Nitrate 5%

Sodium Fluoride . 0.15%

Purpose

Antihypersensitivity

Anticavity

Use

Builds increasing protection against painful sensitivity of the teeth due to cold , heat , acids, sweets or contact.

Aids in the prevention of dental cavities

Warning

Stop use and ask a dentist if

The problem persists or worsens. Sensitive teeth may indicate a serious problem that may prompt care by a dentist

Pain/sensitivity still persists after 4 weeks of use

Directions

Adults and children 12 years of age and older

Apply at least at 1-inch strip of product onto a soft bristle toothbrush

Brush teeth thoroughly for at least 1 minute twice a day( morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing , Spit out after brushing.

Children under 12 years of age:consult a dentist or doctor

Inactive Ingredients

calcium carbonate , water, sorbitol , silica, polyethylene glycol 400, sodium laury alcohol, sodium carboxymethyl cellulose, flavor, sodium saccharin, methylparaben, propyparaben , sodium hydroxide

Keep out of reach of children under 6 years of age

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IODENT SENSITIVE 
potassium nitrate,sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72129-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)
SORBITOL (UNII: 506T60A25R)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72129-002-01	24 in 1 BOX	02/02/2018
1		12 in 1 PACKAGE
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/02/2018

Labeler - Zhaoqing Longda Biotechnology Co., Ltd. (546452557)

Establishment
Name	Address	ID/FEI	Business Operations
Zhaoqing Longda Biotechnology Co., Ltd.		546452557	manufacture(72129-002)