ORBITOL- sodium monofluorophosphate paste

Orbitol by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Sodium Monofluorophosphate 0.8% (928 PPM Fluoride Ion)

Purpose

Cavity Prevention

Uses:

• Aids in the prevention of cavities,gingivitis and plaque
  

Warnings:

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.

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:

Sorbitol, Water, Calcium Carbonate, Silica, Cellulose Gum, Sodium Lauryl Sulfate, Flavour, Sodium Saccharin, Sodium Benzoate, Benzoic  Acid, Limonene.

Other information:

Questions?

Call 718-369-4600

Principal Display Panel

ORBITOL

Toothpaste with fluoride and Mint

FLUORIDE and MINT

For preventing Cavities and for a cool, fresh feeling

nt wt 3.5 fl oz (145 gr)

NDC: 69939-311-02

INGREDIENTS AND APPEARANCE

ORBITOL  
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69939-311
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
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69939-311-02	145 g in 1 TUBE; Type 0: Not a Combination Product	07/06/2016	01/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/06/2016	01/30/2022

Labeler - COSMOPHARM LTD. (600395487)

Establishment
Name	Address	ID/FEI	Business Operations
TROPICAL DEGIL COSMETIC INDUSTRIES LTD		600437230	manufacture(69939-311)