MORNING FRESH- sodium monofluorophosphate paste 
Dynarex Corporation

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,Potassium nitrate,  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

Morning Fresh

MORNING FRESH 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-173
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 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)  
POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-173-0143 g in 1 TUBE
2NDC:67777-173-0278 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/05/2013
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 5/2014
Document Id: 640c16fc-0e0f-4b38-a4f7-eedb6b90059e
Set id: cb2217e2-8c99-49d6-bb0d-136c0fa3677e
Version: 1
Effective Time: 20140507
 
Dynarex Corporation