ORBITOL - sodium monofluorophosphate paste 
COSMOPHARM LTD.

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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Orbitol

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

Label

ORBITOL  
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69939-309
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBITOL (UNII: 506T60A25R)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ZINC CITRATE (UNII: K72I3DEX9B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69939-309-02145 g in 1 TUBE; Type 0: Not a Combination Product06/30/201606/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/30/201606/16/2022
Labeler - COSMOPHARM LTD. (600395487)

Revised: 8/2019
Document Id: 90b48ad5-b8e7-5ee7-e053-2995a90a8097
Set id: a3f710f0-eb7e-431c-9224-af15802e6462
Version: 6
Effective Time: 20190822
 
COSMOPHARM LTD.