IODENT SENSITIVE EXTRA WHITENING- sodium fluoride potassium nitrate paste

Iodent Sensitive Extra Whitening by

Drug Labeling and Warnings

Iodent Sensitive Extra Whitening 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. Sensitive teeth mauy indicate a serious problem that may prompt care by a dentist
• pain/sensitivity stil 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 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

STORAGE AND HANDLING

Other information

• sore at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

sorbitol, hydrated silica, water, PEG-1500, sodium lauryl sulfate, flavor, glycerin, cellulose gum, tetrasodium pyrophosphate, titanium dioxide, sodium benzoate, sodium hydroxide, sodium saccharin, trisodium phosphate, methylparaben, propylparaben

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IODENT SENSITIVE EXTRA WHITENING 
sodium fluoride potassium nitrate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-105
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	5 mg  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: 65923-105-04	1 in 1 CARTON	12/21/2016
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	10/23/2014

Labeler - United Exchange Corp. (840130579)