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 TypeHUMAN OTC DRUGItem Code (Source)NDC:72164-101
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72164-101-041 in 1 KIT09/14/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 TUBE 192 g
Part 22 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 AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72164-000-002 in 1 BOX
196 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/14/2018
Part 2 of 2
EARLY BIRD WINTERGREEN AND PEPPERMINT 
potassium nitrate, sodium fluoride paste
Product Information
Item Code (Source)NDC:72164-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72164-001-002 in 1 BOX
196 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/14/2018
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