PRO CARE FLOURIDE- sodium fluoride gel

Pro Care Flouride by

Drug Labeling and Warnings

Pro Care Flouride by is a Otc medication manufactured, distributed, or labeled by DILIGO HOLDINGS JOINT STOCK COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drugs Facts:

Active ingredient

Sodium fluoride 0.21%

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

Other information

Use at least 0.04 oz (1 g) of toothpaste. Close the cap after usage. Keep away from direct sunlight for a long time.

Inactive Ingredients

Cellulose Gum, Hydrate Silica, Flavor, Mica, Organic psidium guajava fruit, PEG-32, Propolis Extract, Sodium Chloride, Sodium Lauryl Sulfate, Sodium Sarcharin, Sorbitol, Troxerutin, Water, Xylitol.

Directions

Adults and children 2 years of age and older. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentis or doctor.
Children under 6 years old of age. Intruct in good brushing and rinsing habits ( to minimize swallowing) Supevise children as necessary until capable of using without supervison.
Children under 2 years old of age. Consult a dentist or doctor.

Package Labeling:

INGREDIENTS AND APPEARANCE

PRO CARE FLOURIDE 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78989-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MICA (UNII: V8A1AW0880)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
TROXERUTIN (UNII: 7Y4N11PXO8)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78989-001-01	1 in 1 BOX	08/05/2020
1		185 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 final	part355	08/05/2020

Labeler - DILIGO HOLDINGS JOINT STOCK COMPANY (555365269)