Mini Duo: Package Insert and Label Information

MINI DUO- potassium nitrate, sodium fluoride
Smiletwice, Inc.

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.

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
(click image for full-size original)

Package Labeling: 72164-001-01

Early Bird
(click image for full-size original)

Package Labeling: 72164-000-02

Twilight
(click image for full-size original)

MINI DUO
potassium nitrate, sodium fluoride kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72164-102
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72164-102-23 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 50 mg in 1 g
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2.4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
HYDRATED SILICA
SORBITOL
GLYCERIN
SODIUM TRIPOLYPHOSPHATE ANHYDROUS
COCAMIDOPROPYL BETAINE
METHYL SALICYLATE
SODIUM ASCORBYL PHOSPHATE
VITAMIN A PALMITATE
TOCOPHEROL
ALOE VERA LEAF
XYLITOL
SACCHARIN SODIUM
SUCRALOSE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
TITANIUM DIOXIDE
SODIUM BENZOATE
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72164-001-02 23 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 50 mg in 1 g
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2.4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
HYDRATED SILICA
SORBITOL
GLYCERIN
SODIUM TRIPOLYPHOSPHATE ANHYDROUS
COCAMIDOPROPYL BETAINE
METHYL SALICYLATE
SODIUM ASCORBYL PHOSPHATE
VITAMIN A PALMITATE
TOCOPHEROL
ALOE VERA LEAF
XYLITOL
SACCHARIN SODIUM
SUCRALOSE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
TITANIUM DIOXIDE
SODIUM BENZOATE
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72164-000-02 23 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 03/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355B 03/01/2020
Labeler — Smiletwice, Inc. (117404286)

Revised: 02/2020 Smiletwice, Inc.

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