DENTAL PLUS REGULAR FLAVOR- sodium monofluorophosphate paste, dentifrice

Dental plus Regular Flavor by

Drug Labeling and Warnings

Dental plus Regular Flavor by is a Otc medication manufactured, distributed, or labeled by Tropical International Manufacturing Inc, Tropical Degil Cosmetics Industries LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug facts

Active Ingredient

Sodium Monofluorophosphate 0.8% (1000 ppm F)

Purpose

anticavity

Use

For cavity prevention and tooth protection.

Warnings

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

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Drug Facts (continued)

Dental plus Regular Flavor 200 g

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

Water, Sorbitol, Calcium Carbonate, Silica, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Sodium saccharin, Sodium Benzoate.

Questions? Comments?

call toll-free 1-888-777-8767. Monday-Friday 9am-5pm

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Made by Tropical Degil Cosmetics

Ind. Ltd. Kiryat Shmona, Israel for

Tropical International Cosmetics, Inc.

18 Stewart Street,

Brooklyn, NY 11207 USA

Made in Israel

PRINCIPAL DISPLAY PANEL - 7 oz Tube

ANTICAVITY FLUORIDE TOOTHPASTE

FIGHTS CAVITIES and TOOTH DECAY

Tropical DEGIL Dental plus REGULAR FLAVOR

NEW GIANT SIZE STAND UP TUBE

GREAT TASTING MINT FLAVOR

NET WT. 7 OZ (200 G)

INGREDIENTS AND APPEARANCE

DENTAL PLUS REGULAR FLAVOR 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62678-217
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: 62678-217-17	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