Drug Facts

Active ingredients

Potassium Nitrate 5% Sodium Fluoride 0.240% (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses

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

Warnings

When using this product,

if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Stop use and ask a dentist

if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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.

Directions

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

Inactive Ingredients

Water, Hydrated Silica, Sorbitol, Glycerin, Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Sodium Acorbyl Phosphate (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.

Package Labeling: KIT 72164-102-23

Kit

Package Labeling: 72164-001-01

Early Bird

Package Labeling: 72164-000-02

Twilight

MINI DUO
potassium nitrate, sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72164-102

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72164-102-23	1 in 1 KIT	03/01/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	23 g
Part 2	1 TUBE	23 g

Part 1 of 2

EARLY BIRD WINTERGREEN AND PEPPERMINT
potassium nitrate, sodium fluoride paste

Product Information
Item Code (Source)	NDC:72164-001
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	2.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XYLITOL (UNII: VCQ006KQ1E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72164-001-02	23 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	03/01/2020

Part 2 of 2

TWILIGHT PEPPERMINT WITH VANILLA AND LAVENDER
potassium nitrate, sodium fluoride paste

Product Information
Item Code (Source)	NDC:72164-000
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	2.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XYLITOL (UNII: VCQ006KQ1E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72164-000-02	23 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	03/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	part355B	03/01/2020

Labeler - Smiletwice, Inc. (117404286)

Mini Toothpaste-Duo KIT