SPEARMINT EUCALYPTUS- potassium nitrate, sodium fluoride paste, dentifrice
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.

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Spearmint Eucalyptus Toothpaste

Drug Facts

Active Ingredients

Potassium nitrate 5%.

Sodium fluoride 0.240% (0.15% w/v fluoride ion).

Purpose

Antisensitivity

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 after meals or at least twice a day or as recommended by a dentist or doctor. Make sure to brush sensitive areas of the teeth. Minimize swallowing.

• Children under 12 years: consult a dentist or doctor.

Inactive Ingredients

• Water, Hydrated Silica, Sorbitol, Glycerin (Vegetable), Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, 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:

Label03 Label04

SPEARMINT EUCALYPTUS
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72164-006
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	1.5 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)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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:72164-006-00	96 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	03/01/2022

Labeler - Smiletwice, Inc. (117404286)

Revised: 11/2021

Document Id: d15eef66-8d55-c1c7-e053-2a95a90abcdb

Set id: 2e0698aa-369a-4a02-b648-82342cba9a10

Version: 1

Effective Time: 20211122

Smiletwice, Inc.