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Orbitol by COSMOPHARM LTD.

Medically reviewed on December 5, 2016

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.40g in 100g
Labeler: COSMOPHARM LTD.
NDC Code: 69939-313

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.

Drug Facts

ACTIVE INGREDIENTS

Sodium Monofluorophosphate 0.40% (500 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 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, Cellulose Gum, Sodium Lauryl Sulfate, Flavour, Sodium Bicarbonate, Sodium Saccharin, Sodium Benzoate, Benzoic Acid, FD and C Red No 40, Linalool.

Other information

Questions?

Call 718-369-4600

Principal Display Panel

NDC 69939-313-02


ORBITOL Kids' Mate

contains Fluoride

Fun Strawberry-Flavored Children's Toothpaste for Healthy Teeth

nt wt. 3.5 fl oz (145 gr)






ORBITOL  
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69939-313
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.40 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
CALCIUM CARBONATE 
SILICON DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM 
SODIUM BENZOATE 
BENZOIC ACID 
LINALOOL, (+/-)- 
FD&C RED NO. 40 
Packaging
#Item CodePackage Description
1NDC:69939-313-02145 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/05/2016
Labeler - COSMOPHARM LTD. (600395487)
Establishment
NameAddressID/FEIOperations
TROPICAL DEGIL COSMETIC INDUSTRIES LTD600437230manufacture(69939-313)

 
COSMOPHARM LTD.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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