ORBITOL- sodium monofluorophosphate paste

Orbitol by

Drug Labeling and Warnings

Orbitol by is a Otc medication manufactured, distributed, or labeled by COSMOPHARM LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ORBITOL  
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69939-309
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69939-309-02	145 g in 1 TUBE; Type 0: Not a Combination Product	06/30/2016	06/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/30/2016	06/16/2022

Labeler - COSMOPHARM LTD. (600395487)