Orbitol by COSMOPHARM LTD. / Emilia Cosmetics Ltd Orbitol

Orbitol by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 0.74% (900 PPM Fluoride Ion)

Purpose

Cavity Prevention

Uses

• Helps protect against cavities.
  

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 for which it was intended and according to its instructions.

Do not ingest.

Directions

• Adults and children 2 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 physician
  
• Children 2 to 6 years use only a pea sized amount and supervised child's brushing and rinsing (to minimized swallowing)
• Children under 2 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, Benzoic Acid, Menthyl Lactate, Zinc Citrate, Limonene

Other information

Questions?

Call (845) 501-0127

Principal Display Panel

Special edition

Kosher For Passover

under Badatz supervision

ORBITAL Kids' Mate

Mint-Candy Flavored

Mint-Candy Flavored Children's Toothpaste For Your Health and Enjoyment

NDC: 69939-323-02

nt wt 3.5 fl oz (145 gr)

ORBITOL 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69939-323
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.74 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZOIC ACID (UNII: 8SKN0B0MIM)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
ZINC CITRATE (UNII: K72I3DEX9B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69939-323-02	145 g in 1 TUBE; Type 0: Not a Combination Product	02/08/2016	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/08/2016	09/01/2019

Labeler - COSMOPHARM LTD. (600395487)

Establishment
Name	Address	ID/FEI	Business Operations
Emilia Cosmetics Ltd		600076624	manufacture(69939-323)

Revised: 8/2019

Document Id: 90b7cce4-7fdf-6c1b-e053-2a95a90a1e7e

34390-5

Set id: d9d86dbd-ade5-4d49-947b-f616c0d3629d

Version: 4

Effective Time: 20190822

 

COSMOPHARM LTD.