Walgreens Anticavity and Antigingivitis Whitening: Package Insert and Label Information

WALGREENS ANTICAVITY AND ANTIGINGIVITIS WHITENING — sodium fluoride paste, dentifrice
Walgreen

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.

Active Ingredient

Sodium Fluoride 0.234% (0.15% w/v fluoride ion……………………..Anticavity toothpaste

As with all fluoride toothpastes, keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact the Poison Control Center immediately.

Directions

Adults and children 6 years or older
Brush Teeth throughly, preferably after each meal, or at least twice a day, or as directed by your dentist. Do not swallow.

Children between 6 years and 12 years To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established.

Children under 6 years Ask a dentist or physician,


Inactive Ingredients

Sorbitol, Silica, Water, Glycerin, Sodium Laurel Sulphate, Zinc Citrate, Titanium Dioxide, Cellulose Gum, Flavor, PVP, Sodium Benzoate, Tetrasodium Pyrophosphate, Sodium Saccharine, Sodium Hydroxide, Carrageenan, Mica, FDC Blue No. 1.

Principal Display Panel

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USE

Helps protect against cavities.

WALGREENS ANTICAVITY AND ANTIGINGIVITIS WHITENING
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9529
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (FLUORIDE ION) Sodium Fluoride 2.43 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Sorbitol
SILICON DIOXIDE
Water
Glycerin
SODIUM LAURYL SULFATE
Zinc Citrate
Titanium Dioxide
CROSCARMELLOSE SODIUM
SODIUM BENZOATE
SODIUM PYROPHOSPHATE
SACCHARIN SODIUM
SODIUM HYDROXIDE
Carrageenan
FD&C BLUE NO. 1
Product Characteristics
Color white Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-9529-10 24 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 11/24/2008
Labeler — Walgreen (008965063)

Revised: 11/2011 Walgreen

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