SENSITIVE TEETH- potassium nitrate paste

Sensitive Teeth by

Drug Labeling and Warnings

Sensitive Teeth by is a Otc medication manufactured, distributed, or labeled by The Green Beaver Company Ltd., Dermolab Pharma Ltee. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Postassium nitrate, 5%

PURPOSE

Purpose

Antisensitivity

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Use builds increasing protection against painful sensitivity of the teeth to cold, acids, sweets, or contact

WARNINGS

Warnings

When using this product, if pain/sensitivity still persists after 4 weeks or use, please visit your dentist

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years of age and older
• Apply at least a 1-inch strip of the product onto soft bristle toothbrush
• Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist
• Make sure to brush all sensitive areas of the teeth
• Children under 12 years of age: consult a dentist or doctor

INACTIVE INGREDIENT

Inactive ingredients

Calcium carbonate, Sorbitol, Agua, Glycerin, Hydrate Silica, Xynthol, Coco-glucoside, Xanthan Gum, Mentha Viridis (Spearmint) Leaf Oil, Menthol, Leuconostoc/Radish Root Ferment Filtrate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENSITIVE TEETH 
potassium nitrate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76098-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
COCO GLUCOSIDE (UNII: ICS790225B)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHA SPICATA (UNII: O2H83I4PUN)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76098-001-01	75 mL in 1 BOX; Type 0: Not a Combination Product	07/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/06/2017

Labeler - The Green Beaver Company Ltd. (243807018)

Establishment
Name	Address	ID/FEI	Business Operations
Dermolab Pharma Ltee		245414743	manufacture(76098-001)