POVI DENTAL CARE- sodium fluoride mouthwash

POVI DENTAL CARE by

Drug Labeling and Warnings

POVI DENTAL CARE by is a Otc medication manufactured, distributed, or labeled by DOCTOR PHARM. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Flouride

PURPOSE

Keeps it white and makes it strong.
Keep your mouth clean.
Refreshes the oral cavity.
Prevents tooth decay and removes bad breath.
Increases aesthetic effect.
Prevention of gingivitis, periodontitis (alveolar fistula)
Prevention of periodontal disease
Prevention of gum disease

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Adults and children 6 years of age and older: Use twice a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: consult a dentist or doctor.

WARNINGS

1.Maintain certain usage and capacity.
2.When using it for children, use it under the guidance and supervision of the guardian.
3.Do not swallow this product.
4.Use only for mouthwash. Do not use for any purpose other than use. If you swallow a large amount, consult your doctor immediately.
5.Children under 6 years of age should not be used without instructions from pharmacists or doctors.
5.Keep out of reach of children.
6.Avoid direct sunlight and keep it as cool as possible. 8) Do not insert any other containers for quality preservation.
7.Do not administer to the next patient.
1).Patients with iodine intolerance
2).Patients with thyroid dysfunction
3).Pregnant women or breastfeeding women who may be pregnant or pregnant

INACTIVE INGREDIENT

Water, glycerin, ethyl alcohol, xylitol, sodium bicarbonate, flavor, citric acid hydrate, enzymatically modified stevia, sodium benzoate, sodium chloride, caramel color, povidone iodide topical solution, l-menthol

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POVI DENTAL CARE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81017-0001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARAMEL (UNII: T9D99G2B1R)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
LEVOMENTHOL (UNII: BZ1R15MTK7)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POVIDONE (UNII: FZ989GH94E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81017-0001-1	110 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/05/2020

Labeler - DOCTOR PHARM (695222920)

Registrant - DOCTOR PHARM (695222920)

Establishment
Name	Address	ID/FEI	Business Operations
DOCTOR PHARM		695222920	label(81017-0001) , manufacture(81017-0001) , pack(81017-0001)