DENTAL PLUS WHITENING - 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.

----------

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.


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

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)

Principal Display Panel - 6 oz Tube

For best results, squeeze tube from

the bottom and flatten as you go up

DENTAL PLUS WHITENING 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62678-216
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:62678-216-161 in 1 CARTON
1172 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: d7743258-adbd-4b4b-a382-5479f0e640e4
Set id: c7de206f-2909-48df-b399-3e668b877669
Version: 1
Effective Time: 20100519
 
Tropical International Manufacturing Inc