POVI DENTAL CARE- sodium fluoride mouthwash 
DOCTOR PHARM

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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DOCTOR PHARM - POVI DENTAL CARE MOUTHWASH

Sodium Flouride

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

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.

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

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

For dental use only

label22

POVI DENTAL CARE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81017-0001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81017-0001-1110 mL in 1 BOTTLE; Type 0: Not a Combination Product11/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/05/2020
Labeler - DOCTOR PHARM (695222920)
Registrant - DOCTOR PHARM (695222920)
Establishment
NameAddressID/FEIBusiness Operations
DOCTOR PHARM695222920label(81017-0001) , manufacture(81017-0001) , pack(81017-0001)

Revised: 11/2020
Document Id: b3a3044d-a177-4731-e053-2995a90a99ef
Set id: b3a30cef-251a-099e-e053-2995a90ad2a5
Version: 1
Effective Time: 20201106
 
DOCTOR PHARM