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 Type HUMAN OTC DRUG Item Code (Source) NDC:68747-6038
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.43 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color      Score     
Shape Size
Flavor MINT (MINT) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68747-6038-1 24 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR 01/01/2013
Labeler - Dabur India Limited (650319218)
Establishment
Name Address ID/FEI Business Operations
Dabur India Limited 650599231 MANUFACTURE(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