SODIUM MONOFLUOROPHOSPHATE- white toothpaste paste

Sodium Monofluorophosphate by

Drug Labeling and Warnings

Sodium Monofluorophosphate by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity

Use(s)

Helps protect against cavities

Warnings

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediatley.

Keep out of reach of children

Keep out of reach of childen under 6 years of age

Directions

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

Children under 6 years: To minimize swallowing, use a pea sized amount and supervise child's brushing and rinsing until good habits are established.

Children under 2 years: Ask a dentist or physician.

Inactive Ingredients

Calcium Carbonate, Carboxymethylcellulose Sodium, Hydrated Silica, Peppermint Oil, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Silicate, Sorbitol, Titanium Dioxide

Other Information

Store between 15°-35ºC (59º-95ºF)

Questions?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Label

5910 White Toothpaste

Label

5911 White Toothpaste

Label

5912 White Toothpaste

Label

5913 White Toothpaste

Label

5914 White Toothpaste

INGREDIENTS AND APPEARANCE

SODIUM MONOFLUOROPHOSPHATE 
white toothpaste paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-181
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	760 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM SILICATE (UNII: IJF18F77L3)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-181-02	144 in 1 CASE	07/16/2024
1	NDC: 67777-181-01	42.5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 67777-181-04	144 in 1 CASE	07/16/2024
2	NDC: 67777-181-03	78 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 67777-181-07	60 in 1 CASE	07/16/2024
3	NDC: 67777-181-06	1 in 1 BOX
3	NDC: 67777-181-05	130 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 67777-181-10	720 in 1 CASE	07/16/2024
4	NDC: 67777-181-09	144 in 1 BOX
4	NDC: 67777-181-08	24 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 67777-181-13	720 in 1 CASE	07/16/2024
5	NDC: 67777-181-12	144 in 1 BOX
5	NDC: 67777-181-11	17 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/16/2024

Labeler - Dynarex Corporation (008124539)