MORNING FRESH- sodium monofluorophosphate paste 
Choice Laboratories 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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Toothpaste

Active Ingredient

Sodium Monofluorophosphate 0.76 %

Purpose: Anticavity

Use

Inactive Ingredient

Calcium carbonate, Carboxymethycellulose sodium, Flavour, Hydrated silica, Purified water, Saccharin sodium, Sodium benzoate, Sodium lauryl sulfate, Sorbitol

Dosage and Administration

Directions:

Indications and Usage

Warnings

Keep out of reach of children.

Keep out of reach of children under 6 years of age.

Principal Display Panel

Choice Laboratories Ltd

Toothpaste

Choice Ver Toothpaste.jpg

Toothpaste

MORNING FRESH 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63174-172
Route of AdministrationORAL
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
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63174-172-0143 g in 1 TUBE
2NDC:63174-172-0278 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/05/2013
Labeler - Choice Laboratories Limited (650070394)

Revised: 4/2013
Document Id: 0f34f883-7781-46ff-aa86-842bf5cf1837
Set id: 9baba0ca-f6ac-4963-a92a-1b92ac46c75c
Version: 1
Effective Time: 20130411
 
Choice Laboratories Limited