Label: DENTAL PLUS EXTRA MENTA- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 62678-206-06 - Packager: Tropical International Manufacturing Inc
- Category: HUMAN OTC DRUG LABEL
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 May 19, 2010
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
- SPL UNCLASSIFIED SECTION
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Directions
Adults and children 2 years of age and older
Children 2 to 6 years
Children under 2 years
Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by dentist or physician.
Use only a pea-sized amount and supervise child brushing and rinsing (to minimize swallowing)
Ask a dentist or a physician
- Inactive ingredients
- Questions? Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 7 oz Tube
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INGREDIENTS AND APPEARANCE
DENTAL PLUS EXTRA MENTA
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62678-206 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 8 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62678-206-06 1 in 1 CARTON 1 200 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 05/19/2010 Labeler - Tropical International Manufacturing Inc (962685884) Establishment Name Address ID/FEI Business Operations Tropical Degil Cosmetics Industries LTD 600437230 manufacture, label, pack, analysis