WALGREENS SULFATE FREE- 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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Drug Facts

Active ingredient

Sodium Fluoride 0.24% w/w..................................Purpose: Anticavity

Uses

aids in the prevention of dental caviites

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children under 6 years of age.

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing). Supervise children as necessary until capable of using without supervision.

Other Information

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

Inactive ingredients

water, hydrated silica, sorbitol, stabilized chlorine dioxide, cellulose gum, dibasic sodium phosphate, titanium dioxide, flavor, sodium phosphate, sucralose

Adults and children 2 years of age and older: brush teeth throuoghly, preferably after every meal or at least twice a day, or as directed by a dentist or doctor.

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Carton label

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Tube Label

WALGREENS  SULFATE FREE
fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-8203
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.24 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
Product Characteristics
Color white Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0363-8203-39 1 in 1 CARTON
1 NDC:0363-8203-32 198 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 10/01/2012
Labeler - Walgreens (008965063)
Registrant - Lornamead (126440440)
Establishment
Name Address ID/FEI Business Operations
Lornamead 126440440 manufacture(0363-8203) , pack(0363-8203)

Revised: 11/2012
Document Id: d325bc79-6215-4ccf-afb7-b3b1d6ae77ab
Set id: dee4398e-9795-4b4d-b5b7-f21e0a6c56ea
Version: 1
Effective Time: 20121115
 
Walgreens