SODIUM FLUORIDE- clear mint, gel toothpaste gel

Sodium Fluoride by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

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) immediately.

Keep Out of Reach of Children

Keep out of reach of children under 6 years of age

Directions

Adults and children 2 years of age and older: Brush teeth thoroughtly 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

Carboxymethylcellulose Sodium, Hydrated Silica, Peppermint Oil, Polyethylene Glycol 1450, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol

Other Information

Store between 15º-35ºC (59º-95ºF)

Questions?

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

Label 5900

5900 Clear Mint, Gel Toothpaste

Label 5901

5901 Clear Mint, Gel Toothpaste

Label 5902

5902 Clear Mint, Gel Toothpaste

Label 5903

5903 Clear Mint, Gel Toothpaste

INGREDIENTS AND APPEARANCE

SODIUM FLUORIDE 
clear mint, gel toothpaste gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-180
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	220 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-180-03	720 in 1 CASE	07/16/2024
1	NDC: 67777-180-02	144 in 1 BOX
1	NDC: 67777-180-01	17 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 67777-180-06	60 in 1 CASE	07/16/2024
2	NDC: 67777-180-05	1 in 1 BOX
2	NDC: 67777-180-04	130 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 67777-180-08	144 in 1 CASE	07/16/2024
3	NDC: 67777-180-07	42.5 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 67777-180-11	720 in 1 CASE	07/16/2024
4	NDC: 67777-180-10	144 in 1 BOX
4	NDC: 67777-180-09	24 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)