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Orbitol by COSMOPHARM LTD.

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.8g in 100g
Labeler: COSMOPHARM LTD.
NDC Code: 69939-309

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 ingredients

Sodium Monofluorophosphate 0.8% (1000 PPM Fluoride Ion)

Purpose

Cavity Prevention

Uses:
  • Aids in the prevention of cavities,gingivitis, stains, plaque and whitens teeth

Warnings:

Keep out of reach of children

Keep out of 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 immediately.


Do not use

if you have known sensitivities to any one of the ingredients.


When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.


Other Safety Information

This product should be used only for the purpose it was intended and according to its instructions. Do not ingest.


Directions:
  • Adults and children 6 years of age and older brush teeth thoroughly. Preferably after each meal or at least twice a day or as directed by a dentist or a physician.
  • Children under 6 years ask a dentist or physician

Inactive ingredients:

Water, Sorbitol, Calcium Carbonate, Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, Flavour, Sodium Bicarbonate,Titanium Dioxide, Sodium Saccharin, Sodium Benzoate, Menthyl Lactate, Benzoic  Acid, Zinc Citrate, Limonene.



Other information:

Questions?

Call 718-369-4600

Principal Display Panel

ORBITOL

A Unique Formula for Whitening and Polishing the Teeth

WHITENING

For whitening the teeth

Mint-flavored

nt wt 3.5 fl oz (145 gr)

NDC 69939-309-02

ORBITOL  
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69939-309
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
POLYETHYLENE GLYCOL 1500 
WATER 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
SACCHARIN SODIUM 
SODIUM BENZOATE 
MENTHYL LACTATE, (-)- 
BENZOIC ACID 
SORBITOL 
CALCIUM CARBONATE 
SODIUM BICARBONATE 
ZINC CITRATE 
LIMONENE, (+)-  
Packaging
#Item CodePackage Description
1NDC:69939-309-02145 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/30/2016
Labeler - COSMOPHARM LTD. (600395487)
Establishment
NameAddressID/FEIOperations
TROPICAL DEGILCOSMETIC INDUSTRIES LTD600437230manufacture(69939-309)

Revised: 06/2016
 
COSMOPHARM LTD.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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