SOUND BODY SENSITIVE MAXIMUM STRENGTH- potassium nitrate, sodium fluoride paste, dentifrice 
Big Lots Stores, Inc.

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5820214 Sound Body Max Str Sensitive Toothpaste with Fluoride (8015201)

Drug Facts

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses

Warnings

When using this productdo not use longer than 4 weeks unless recommended by a dentist or physician.

See your dentistif the problem 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 a 1-inch strip of the product onto a soft bristle toothbrush.

Inactive ingredientscocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

Comments/Questions:1-877-777-2743

MANUFACTURED BY:

Lornamead, Inc.

175 Cooper Avenue

Tonawanda, NY 14150

MADE IN USA

SOUND BODY

MAXIMUM STRENGTH

SENSITIVE TOOTHPASTE WITH FLUORIDE

EXTRA WHITENING

NET WT 4 OZ (113 g)

MM1

SOUND BODY SENSITIVE  MAXIMUM STRENGTH
potassium nitrate, sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50594-214
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50594-214-191 in 1 CARTON03/05/2014
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02203/05/2014
Labeler - Big Lots Stores, Inc. (017885351)
Registrant - Lornamead (078584069)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(50594-214)

Revised: 2/2024
Document Id: 11f8f709-0dea-19bb-e063-6294a90a2fb4
Set id: 81a0a712-76e1-133f-e053-2a91aa0a001a
Version: 2
Effective Time: 20240222
 
Big Lots Stores, Inc.