Your browser does not support JavaScript! MORNING FRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE [DYNAREX CORPORATION]
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MORNING FRESH (sodium monofluorophosphate) paste
[Dynarex Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active Ingredient

Sodium Monofluorophosphate 0.76 %

Purpose: Anticavity

Use

  • Aids in the prevention of dental cavities.

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:

  • Adults and children 2 years and older Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
  • Children under 6 years To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established.
  • Children under 2 years Ask a dentist or physician.

Indications and Usage

  • The prevention of dental cavities.

Warnings

  • If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67777-171
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
SILICON DIOXIDE 
CALCIUM CARBONATE 
METHYLPARABEN SODIUM 
PROPYLPARABEN SODIUM 
SACCHARIN SODIUM 
WATER 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-171-0143 g in 1 TUBE
2NDC:67777-171-0278 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/08/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 4/2013
 
Dynarex Corporation

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