EcoDent® Res-Q-Dent®

Drug Labeling and Warnings

Drug Details [pdf]

ECODENT RES-Q-DENT- potassium nitrate paste 
Lotus Brands, 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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EcoDent® Res-Q-Dent®

Active Ingredient

Potassium Nitrate 5.0%

Purpose

tooth desensitizer

Uses

helps reduce and provide increasing protection against painful sensitivity of the teeth to sweets, heat, cold, acids or contact.

Warnings

When using this product do not use for more than 4 weeks unless recommended by a doctor or dentist.

Stop use and ask a doctor or dentist if the problem continues or gets worse. Sensitive teeth may indicate a serious problem requiring prompt care.

Keep out of reach of children. If more than normal brushing amounts is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 12 years and over: apply at least a 1 inch strip of toothpaste onto a soft bristle toothbrush. Brush teeth thoroughly at least one minute twice a day (morning and evening) or as recommended by your doctor or dentist. Make sure to brush all sensitive areas of the teeth.
• Children under 12 years: Ask a doctor or dentist.

Inactive Ingredients

Sorbitol, glycerin, sodium bicarbonate, kaolin USP, carboxymethyl cellulose, sodium cocoyl glutamate, sodium lauryl sarcosinate, xylitol, stevia extract, Citrus paradisi (grapefruit) seed extract, Aloe barbadensis (aloe vera) leaf juice, purified water, hydrated silica, menthol, Mentha spicata (spearmint) oil, sodium ascorbate, calcium ascorbate, boron citrate, zinc citrate.

Questions?

Call weekdays (except legal holidays) from 9 am to 5 pm Central Time at 888-326-3368.

Distributed by
Lotus Brands, Inc. 1100 Lotus Drive
Silver Lake, WI 53170 USA

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

ECODENT®
PREMIUM ORAL CARE PRODUCTS

Spearmint

RES-Q-DENT®
Natural Gel Toothpaste
For Sensitive Teeth
With Potassium Nitrate

Contains Baking Soda
and Xylitol for low
abrasion cleaning

Net Wt. 3 OZ. (85 G)

ECODENT RES-Q-DENT 
potassium nitrate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76328-222
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
KAOLIN (UNII: 24H4NWX5CO)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU)
XYLITOL (UNII: VCQ006KQ1E)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SPEARMINT OIL (UNII: C3M81465G5)
SODIUM ASCORBATE (UNII: S033EH8359)
CALCIUM ASCORBATE (UNII: 183E4W213W)
BORON CITRATE (UNII: S043P4DV22)
ZINC CITRATE (UNII: K72I3DEX9B)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76328-222-01	1 in 1 CARTON	06/01/2013	07/29/2019
1		85 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	06/01/2013	07/29/2019

Labeler - Lotus Brands, Inc. (879022713)

Registrant - Sun Deep Inc. (189788201)

Revised: 10/2019

Document Id: 091c3442-273f-40a9-a13c-fbab4ed3aede

34390-5

Set id: 064061cb-3c63-4789-94de-310c4380d8c7

Version: 2

Effective Time: 20191004