ORBITOL MINT FLAVORED FLUORIDE TOOTHPASTE- sodium monofluorophosphate paste 
tropical degil cosmetics industries ltd

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Orbitol Mint Flavored Fluoride Toothpaste

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 saccharin, sodium benzoate, benzoic acid, limonene.

Other information

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

Principal Display Panel

PDP

ORBITOL MINT FLAVORED FLUORIDE TOOTHPASTE 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62685-231
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
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:62685-231-041 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 DrugM02209/27/2021
Labeler - tropical degil cosmetics industries ltd (600437230)
Establishment
NameAddressID/FEIBusiness Operations
tropical degil cosmetics industries ltd600437230manufacture(62685-231)

Revised: 3/2024
Document Id: 13502ce1-bcdf-78ec-e063-6394a90a4fed
Set id: cd023cb9-0887-7841-e053-2995a90a78ca
Version: 4
Effective Time: 20240310
 
tropical degil cosmetics industries ltd