ORBITOL FLUORIDE WHITENING TOOTHPASTE- 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.

----------

Orbitol Whitening

Active ingredient

Sodium monofluorophosphate 0.8% w/w (1000 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

water, sorbitol, calcium carbonate, silica, peg-32, cellulose gum, sodium lauryl sulfate, sodium bicarbonate, flavor, titanium dioxide, sodium saccharin, sodium benzoate, menthyl lactate, benzoic acid, zinc citrate, limonene

Other information

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

Principal Display Panel

PDP

ORBITOL FLUORIDE WHITENING TOOTHPASTE 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62685-232
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
ZINC CITRATE (UNII: K72I3DEX9B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62685-232-041 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(62685-232)

Revised: 1/2023
Document Id: f183f46a-c11e-f474-e053-2995a90a2256
Set id: cd027a8c-ab59-d1da-e053-2a95a90a9175
Version: 3
Effective Time: 20230105
 
tropical degil cosmetics industries ltd