IODENT SENSITIVE FRESH MINT- potassium nitrate and sodium floride paste

Iodent Sensitive Fresh Mint by

Drug Labeling and Warnings

Iodent Sensitive Fresh Mint by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                        Purpose

Potassium nitrate 5%--------------------------------------------------- Antihypersensitivity

Sodium fluoride (0.15% w/v fluoride ion)------------------------------Anticavity

PURPOSE

Uses

• Builds increasing protection against painful sensitivity of the teeth due to cold, heat, acids, sweets or contact
• aids in the prevention of dental cavities

WARNINGS

Warnings

STOP USE

Stop use and ask a dentist if

• the problem persists or worsens. Sensitivie teeth may indicate a serious problem that may prompt care by a dentist
• pain/sensitivity still persists after 4 weeks of use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

adults and children 12 years of age and older

• apply at least a 1-inch strip of product onto a soft bristle toothbruch
• brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommende 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

STORAGE AND HANDLING

Other Information

• store below 40°C (86°F)
• Lot No & Exp Date:see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

Water, Silica, Sorbitol, Sodium Lauryl Alcohol, Polyethylene Glycol 300, Sodium Carboxymethylcellulose, Floavor, Sodium Sacchrin, Titanium Dioxide, Sodium Pyrophosphate, PEG/PPG 116/66 Copolymer, Color: Lemon Yellow & Bright Blue

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IODENT SENSITIVE FRESH MINT 
potassium nitrate and sodium floride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-101
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 mg  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	.15 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-101-13	1 in 1 CARTON	12/21/2016
1		113 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/23/2014

Labeler - United Exchange Corp. (840130579)