MEIJER MAXIMUM STRENGTH- fluoride paste, dentifrice 
Meijer

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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Drug Facts

Active ingredients / Purpose

Potassium nitrate 5%....................................................Antihypersensitivity

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

Uses

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if 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

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

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

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Carton label

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Tube Label

MEIJER  MAXIMUM STRENGTH
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-160
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 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
FlavorMINT (mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-160-091 in 1 CARTON01/11/2023
1NDC:41250-160-02113 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 finalpart35601/20/2011
Labeler - Meijer (006959555)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(41250-160) , pack(41250-160)

Revised: 1/2023
Document Id: f1fec2eb-752f-e8c8-e053-2995a90a340e
Set id: 9556a24e-888d-415f-9736-25c0da3a382b
Version: 10
Effective Time: 20230111
 
Meijer