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)

Principal Display Panel - 85 g Tube Carton
ECODENT RES-Q-DENT 
potassium nitrate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76328-222
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Potassium Nitrate (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) Potassium Nitrate50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76328-222-011 in 1 CARTON06/01/201307/29/2019
185 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 FINALpart35606/01/201307/29/2019
Labeler - Lotus Brands, Inc. (879022713)
Registrant - Sun Deep Inc. (189788201)

Revised: 10/2019
 

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