GOODSENSE SENSITIVE EXTRA WHITENING- potassium nitrate, and sodium fluroide paste

Goodsense Sensitive Extra Whitening by

Drug Labeling and Warnings

Goodsense Sensitive Extra Whitening by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn, Inc.. 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 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/sensitivty still persists after 4 weeks of use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age. 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
• appy at least 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

• store below 30°C (86°F)
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients sorbitol, water, hydrated silica, cocamidopropyl betaine, PEG 1500, flavor, cellulose gum, titanium dioxide, sodium saccharin, menthol, tetrasodium pyrophosphate

DOSAGE & ADMINISTRATION

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOODSENSE SENSITIVE EXTRA WHITENING 
potassium nitrate, and sodium fluroide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-780
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-780-04	1 in 1 BOX	12/29/2015
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	12/29/2015

Labeler - Geiss, Destin & Dunn, Inc. (076059836)