DENTAL PLUS REGULAR FLAVOR - sodium monofluorophosphate paste, dentifrice 
Tropical International Manufacturing Inc

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.

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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.


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

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)

Principal Display Panel - 7 oz Tube

DENTAL PLUS REGULAR FLAVOR 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62678-217
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE8 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62678-217-171 in 1 CARTON
1200 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/19/2010
Labeler - Tropical International Manufacturing Inc (962685884)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Degil Cosmetics Industries LTD600437230manufacture, label, pack, analysis

Revised: 5/2010
Document Id: 07e7c00b-174e-4de7-99c2-10c5533183b1
Set id: 639902fa-4b55-4d19-8327-61d19c9fa952
Version: 1
Effective Time: 20100519
 
Tropical International Manufacturing Inc