MEDICHOICE- 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.

----------

Drug Facts

ACTIVE INGREDIENT

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

PURPOSE

Anticavity

USE

Aids in the prevention of denial cavities

WARNINGS

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

  • Adults and children 2 years of age and olden Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years of age should use only a pea-sized amount in order to minimize swallowing. Supervise children and help them create good brushing and rinsing habits until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or a doctor.

INACTIVE INGREDIENTS

sorbitol, silica, water, glycerin, polythelene glycol 1500, sodium lauryl sulfate, flavor, titanium dioxide, cellulose gum, carrageenan, trisodium orthophosphate, sodium saccharin, sodium benzoate, tetrasodium pyrophosphate, methylparaben, propylparaben, FD & C blue #1

Made in India, Distributed by Owens & Minor, 9120 Lockwood Boulevard, Mechanicsville, VA 23116

C.No. DNH/COS/DNH/52
Exp. Date & Lot No. on Crimp Rev. A

Principal Display Panel – 0.85oz Tube Label

NDC 39892-0603-2

MediChoice®

Fluoride Toothpaste

cool mint

fights cavities

smooth texture
gentle formula

Reorder No. PC7385

NET WT. 0.85 0Z.
(24 GRAMS)

Principal Display Panel – 0.85oz Tube Label
MEDICHOICE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68747-6037
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorFRUIT (FRUIT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68747-6037-124 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 Distributor09/28/2012
Labeler - Dabur India Limited (650319218)
Establishment
NameAddressID/FEIBusiness Operations
Dabur India Limited650599231MANUFACTURE(68747-6037)

Revised: 8/2008
 
Dabur India Limited