DENTAL PLUS WHITENING- sodium monofluorophosphate paste, dentifrice

Dental plus Whitening by

Drug Labeling and Warnings

Dental plus Whitening 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% (1,000 ppmF)

Purpose

anticavity

Use

For cavity prevention, Tooth Protection and Whiter Teeth.

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 Whitening 172g

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, PEG-32, Sodium Lauryl Sulphate, Cellulose Gum, Sodium Bicarbonate, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Benzoate, Zinc Citrate

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 - 6 oz Tube

ANTICAVITY FLUORIDE TOOTHPASTE

Tropical DEGIL Dental plus Whitening

FOR HEALTHY AND BRIGHT TEETH

NET WT.6 OZ (172 G) Cont. Neto: 6 oz (172 G)

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For best results, squeeze tube from

the bottom and flatten as you go up

INGREDIENTS AND APPEARANCE

DENTAL PLUS WHITENING 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62678-216
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: 62678-216-16	1 in 1 CARTON
1		172 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