WALGREENS SENSITIVE EXTRA WHITENING- sodium fluoride paste, dentifrice 
Walgreens

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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Potassium Nitrate 5% Antihypersensitivity

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

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

Kep out of reach of children. If more tahn used for brushing is accidentally swallowed, get medical help or contact a poisoin control center right away.

When using this product, if irritation occurs discontinue use. 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. Pain/sensitivity still persists after 4 weeks of use.

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact. Aids in the prevention of dental cavities.

Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 time a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: consult a dentist or doctor.

Store below 30C (86F).

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WALGREENS SENSITIVE EXTRA WHITENING 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1588
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1588-091 in 1 BOX10/28/2022
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 finalpart35510/28/2022
Labeler - Walgreens (008965063)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(0363-1588) , pack(0363-1588)

Revised: 10/2022
Document Id: ec1978ce-e5c2-1654-e053-2995a90a47a8
Set id: e807b8a0-6d58-a15f-e053-2995a90a2ea1
Version: 2
Effective Time: 20221028
 
Walgreens