Sodium Fluoride 5000 PPM (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 100 mL Tube Carton

SPEARMINT
NDC 69367-311-01
Rx Only

Sodium Fluoride 5000 ppm
1.1% Sodium Fluoride Prescription Strength Toothpaste

3.4 FL OZ (100 mL)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 100 mL Tube Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mL Tube Carton — FRUITY

FRUITY
NDC 69367-312-01
Rx Only

Sodium Fluoride 5000 ppm
1.1% Sodium Fluoride Prescription Strength Toothpaste

3.4 FL OZ (100 mL)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 100 mL Tube Carton -- FRUITY
(click image for full-size original)
SODIUM FLUORIDE 5000 PPM
sodium fluoride paste
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-311
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM BENZOATE
SACCHARIN SODIUM
TITANIUM DIOXIDE
SODIUM PYROPHOSPHATE
SORBITOL
FD&C BLUE NO. 1
HYDRATED SILICA
GLYCERIN
XANTHAN GUM
SODIUM LAURYL SULFATE
Product Characteristics
Color BLUE Score
Shape Size
Flavor SPEARMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-311-01 100 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/16/2021
SODIUM FLUORIDE 5000 PPM
sodium fluoride paste
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-312
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM BENZOATE
SACCHARIN SODIUM
TITANIUM DIOXIDE
SODIUM PYROPHOSPHATE
SORBITOL
FD&C RED NO. 40
HYDRATED SILICA
GLYCERIN
XANTHAN GUM
SODIUM LAURYL SULFATE
Product Characteristics
Color PINK Score
Shape Size
Flavor FRUIT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-312-01 100 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/16/2021
Labeler — Westminster Pharmaceuticals, LLC (079516651)

Revised: 06/2021 Westminster Pharmaceuticals, LLC

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