4 PACK- potassium nitrate, sodium fluoride 
Twice Smiles LLC

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.

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4 Pack

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 Ascorbyl 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.

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.

Twilight Peppermint with Vanilla and Lavender Toothpaste, 96g (72164-000-00)

Label2

Early Bird Wintergreen and Peppermint Toothpaste 96g (72164-001-00)

Label

4 PACK 
potassium nitrate, sodium fluoride kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72164-101
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:72164-101-04 1 in 1 KIT 09/14/2018
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 TUBE 192 g
Part 2 2 TUBE 192 g
Part 1 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
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 2.4 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:72164-000-00 2 in 1 BOX
1 96 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 09/14/2018
Part 2 of 2
EARLY BIRD WINTERGREEN AND PEPPERMINT 
potassium nitrate, sodium fluoride paste
Product Information
Item Code (Source) NDC:72164-001
Route of Administration DENTAL
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 2.4 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:72164-001-00 2 in 1 BOX
1 96 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 09/14/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 09/14/2018
Labeler - Twice Smiles LLC (081061747)

Revised: 9/2018
Document Id: 754a1ea1-121b-066f-e053-2991aa0a33a9
Set id: c3707c03-3761-4901-89c4-11d214c9287d
Version: 2
Effective Time: 20180907
 
Twice Smiles LLC