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, Methylparaben sodium, Propylparaben sodium, Purified water, Saccharin sodium, Silicon dioxide, 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

Toothpaste.jpg

Toothpaste

MORNING FRESH 
sodium monofluorophosphate paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-171
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67777-171-01 43 g in 1 TUBE
2 NDC:67777-171-02 78 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 06/08/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 4/2013
Document Id: d7333da1-d49a-4966-b31b-35aa1f81665e
Set id: 8840080a-1068-4072-afcd-3e27f44f7bab
Version: 5
Effective Time: 20130411
 
Dynarex Corporation