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, whitening 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:

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

Other information:

Questions?

Call 718-369-4600

Principal Display Panel

ORBITOL

Toothpaste with fluoride and baking soda

FLUORIDE and BAKING SODA

For whitening the teeth and preventing cavities

nt wt 3.5 fl oz (145 gr)

NDC 69939-310-02

Label

ORBITOL
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69939-310
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SORBITOL (UNII: 506T60A25R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
ZINC CITRATE (UNII: K72I3DEX9B)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69939-310-02	145 g in 1 TUBE; Type 0: Not a Combination Product	07/06/2016	01/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/06/2016	01/31/2022

Labeler - COSMOPHARM LTD. (600395487)

Revised: 8/2019

Document Id: 90b47c91-2a77-833c-e053-2a95a90acb20

Set id: f266abda-5cb0-4b97-9479-16a51dfc3146

Version: 4

Effective Time: 20190822

COSMOPHARM LTD.