FRESHMINT PREMIUM ANTICAVITY- sodium fluoride paste, dentifrice 
Dabur India Limited

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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Drug Facts

ACTIVE INGREDIENT:

Sodium Fluoride - 0.243% (0.15% w/v fluoride ion)

PURPOSE:

Anticavity

USES:

Helps protect teeth and roots against cavities.

WARNINGS:

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

DIRECTIONS:

INACTIVE INGREDIENTS:

Sorbitol, Silica, Treated Water (Aqua), Glycerin, Polyethylene Glycol 1500, Sodium Lauryl Sulphate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, Methylparaben, Propylparaben, Color: FD & C Blue # 1.

Principal Display Panel – Tube Label

ADA
Accepted
American
Dental
Association®

freshmint®

Premium Anticavity Toothpaste

NET WT. 0.85 oz

Principal Display Panel – Tube Label
FRESHMINT PREMIUM ANTICAVITY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68747-6038
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
SILICON DIOXIDE 
WATER 
GLYCERIN 
POLYETHYLENE GLYCOL 1500 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
CARRAGEENAN 
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE 
SACCHARIN SODIUM DIHYDRATE 
SODIUM BENZOATE 
SODIUM PYROPHOSPHATE 
METHYLPARABEN 
PROPYLPARABEN 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68747-6038-124 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR01/01/2013
Labeler - Dabur India Limited (650319218)
Establishment
NameAddressID/FEIBusiness Operations
Dabur India Limited650599231MANUFACTURE(68747-6038)

Revised: 8/2008
Document Id: b9087431-c1ac-481c-90e1-e93e97e58bcf
Set id: 19605e5a-f1cd-4b7b-856c-7d4305baba7e
Version: 1
Effective Time: 20080825
 
Dabur India Limited