Label: POVI DENTAL CARE- sodium fluoride mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 81017-0001-1 - Packager: DOCTOR PHARM
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 6, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
POVI DENTAL CARE
sodium fluoride mouthwashProduct 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)
