ORBITOL FLUORIDE TOOTHPASTE WITH BAKING SODA- sodium monofluorophosphate paste 
tropical degil cosmetics industries 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 Fluoride Toothpaste with Baking Soda

Active ingredient

Sodium monofluorophosphate 1.1% w/w (1450 ppm fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Do not use

Do not use if you are sensitive to any of the ingredients in this prouduct.

When using this product

When using this product avoid contact with eyes.

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 right away.

Directions

Inactive ingredients

sorbitol, water, calcium carbonate, silica, cellulose gum, sodium lauryl sulfate, flavor, sodium bicarbonate, sodium saccharin, sodium benzoate, benzoic acid, zinc citrate, limonene.

Other information

Other information store below 30°C (86°F).

Principal Display Panel

PDP

ORBITOL FLUORIDE TOOTHPASTE WITH BAKING SODA 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62685-230
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
ZINC CITRATE (UNII: K72I3DEX9B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62685-230-041 in 1 BOX09/27/2021
1145 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/27/2021
Labeler - tropical degil cosmetics industries ltd (600437230)
Establishment
NameAddressID/FEIBusiness Operations
tropical degil cosmetics industries ltd600437230manufacture(62685-230)

Revised: 1/2023
Document Id: f183f9bf-5589-4a99-e053-2995a90a0878
Set id: cd018c44-3257-3ed6-e053-2a95a90ae3f3
Version: 3
Effective Time: 20230105
 
tropical degil cosmetics industries ltd