Sodium Fluoride and Potassium Nitrate (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 100 mL Tube Carton

MILD MINT

NDC 69367-318-01
Rx Only

Sodium Fluoride 5000 ppm Sensitive

1.1% Sodium Fluoride, 5% Potassium Nitrate
Prescription Strength Toothpaste for Sensitive Teeth

3.4 FL OZ (100 mL)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 100 mL Tube Carton
(click image for full-size original)
SODIUM FLUORIDE AND POTASSIUM NITRATE
sodium fluoride and potassium nitrate gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-318
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 5.8 mg in 1 mL
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 57.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM BENZOATE
SACCHARIN SODIUM
TITANIUM DIOXIDE
SODIUM PYROPHOSPHATE
SORBITOL
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
HYDRATED SILICA
GLYCERIN 1-METHYL ETHER
GLYCERIN 2-METHYL ETHER
XANTHAN GUM
SODIUM LAURYL SULFATE
Product Characteristics
Color GREEN Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-318-01 1 TUBE in 1 CARTON contains a TUBE
1 100 mL in 1 TUBE This package is contained within the CARTON (69367-318-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/15/2022
Labeler — Westminster Pharmaceuticals, LLC (079516651)

Revised: 06/2022 Westminster Pharmaceuticals, LLC

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