Label: DENTAL PLUS REGULAR FLAVOR- sodium monofluorophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 62685-217-03 - Packager: tropical degil cosmetics industries ltd
- 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 February 24, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- WARNINGS
- Ask a dentist before use if you have
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Adults and children 2 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
- Children under 2 years of age: Consult a dentist or doctor.
- Inactive ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENTAL PLUS REGULAR FLAVOR
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62685-217 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) BENZOIC ACID (UNII: 8SKN0B0MIM) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM BENZOATE (UNII: OJ245FE5EU) CALCIUM CARBONATE (UNII: H0G9379FGK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62685-217-03 1 in 1 BOX 02/01/2021 1 145 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 02/01/2021 Labeler - tropical degil cosmetics industries ltd (600437230) Establishment Name Address ID/FEI Business Operations tropical degil cosmetics industries ltd 600437230 manufacture(62685-217)