PRO CARE FLOURIDE- sodium fluoride gel 
DILIGO HOLDINGS JOINT STOCK COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pro Care Flouride Toothpaste

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:

Bottle

PRO CARE FLOURIDE 
sodium fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78989-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78989-001-011 in 1 BOX08/05/2020
1185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/05/2020
Labeler - DILIGO HOLDINGS JOINT STOCK COMPANY (555365269)

Revised: 8/2020
Document Id: ac8aa365-f122-366d-e053-2a95a90a0379
Set id: ac8a9fd0-5447-2ade-e053-2a95a90a36d9
Version: 1
Effective Time: 20200810
 
DILIGO HOLDINGS JOINT STOCK COMPANY