WALGREENS STAIN CARE- 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, sodium bicarbonate, glycerin, sorbitol, hydrated silica, PEG-8, tetrasodium pyrophosphate, sodium carbonate peroxide, flavor, propylene glycol, cellulose gum, sodium lauroyl sarcosinate, sodium lauryl sulfate, titanium dioxide, sodium benzoate, sodium saccharin

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  STAIN CARE
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-8204
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.243 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SACCHARIN SODIUM 
SORBITOL 
HYDRATED SILICA 
WATER 
SODIUM PERCARBONATE 
SODIUM BENZOATE 
TITANIUM DIOXIDE 
SODIUM PYROPHOSPHATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM BICARBONATE 
SODIUM LAUROYL SARCOSINATE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-8204-491 in 1 CARTON
1NDC:0363-8204-42170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/01/2012
Labeler - Walgreens (008965063)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(0363-8204), pack(0363-8204)

Revised: 11/2012
Document Id: a7f923e7-43a3-468a-a1e6-6f61c5d0d9b1
Set id: 6b84837f-d052-438d-86e2-07743625eb8e
Version: 1
Effective Time: 20121115
 
Walgreens