Sensitive Teeth: Package Insert and Label Information

SENSITIVE TEETH- potassium nitrate paste
The Green Beaver Company Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Postassium nitrate, 5%

Purpose

Antisensitivity

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

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

Warnings

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

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 ingredients

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

SENSITIVE TEETH potassium nitrate paste

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 5 g in 100 mL

Inactive Ingredients Ingredient Name Strength LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE COCO GLUCOSIDE CALCIUM CARBONATE SORBITOL XYLITOL GLYCERIN WATER HYDRATED SILICA XANTHAN GUM MENTHA SPICATA MENTHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76098-001-01 75 mL in 1 BOX None

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	Operations
Dermolab Pharma Ltee		245414743	manufacture (76098-001)

Revised: 08/2017 The Green Beaver Company Ltd.