DENTAL PLUS WHITENING- 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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Dental Plus Whitening

Active Ingredient

Sodium monofluorophosphate 0.8% (1,000 ppm F)

Purpose

anticavity

Use

Aids in the prevention of dental cavities

Ask a dentist before use if you have

bleeding or redness lasting more than 2 weeks, pain, swelling, pus, loose teeth, or more spacing between teeth. These may be signs of periodontitis, a serious form of gum disease.

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, sodium lauryl sulphate, flavor, cellulose gum, sodium bicarbonate, flavor, titanium dioxide, sodium saccharin, sodium benzoate, benzoic acid, zinc citrate

Questions or comments? www.sleeksensation.com

Dental Plus Whitening

Anticavity Fluoride Toothpaste

Net Wt 5.1 oz (145 g)

Front Panel

DENTAL PLUS WHITENING 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62685-216
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ZINC CITRATE (UNII: K72I3DEX9B)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62685-216-031 in 1 BOX02/01/2021
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 finalpart35502/01/2021
Labeler - tropical degil cosmetics industries ltd (600437230)
Establishment
NameAddressID/FEIBusiness Operations
tropical degil cosmetics industries ltd600437230manufacture(62685-216)

Revised: 2/2021
Document Id: bc1a446e-5a5a-7558-e053-2a95a90adeea
Set id: bc1a446e-5a59-7558-e053-2a95a90adeea
Version: 1
Effective Time: 20210224
 
tropical degil cosmetics industries ltd