MORNING FRESH- sodium fluoride paste

Morning Fresh by

Drug Labeling and Warnings

Morning Fresh by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Monofluorophosphate 0.76 %

Purpose: Anticavity

Use

• Aids in the prevention of dental cavities.

Inactive Ingredient

Calcium carbonate, Carboxymethylcellulose sodium, Flavour, Methylparaben, Polyethyene glycol 400, Propylparaben, Saccharin sodium, Silicon dioxide, Sodium benzoate, Sodium lauryl sulphate, Sodium pyrophosphate, Sodium silicate, Sorbitol, Titanium dioxide, Water

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

Dynarex Morning Fresh Toothpaste

Morning Fresh.jpg

INGREDIENTS AND APPEARANCE

MORNING FRESH 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-175
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	76 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CALCIUM CARBONATE (UNII: H0G9379FGK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-175-01	43 g in 1 TUBE; Type 0: Not a Combination Product	10/14/2014
2	NDC: 67777-175-02	78 g in 1 TUBE; Type 0: Not a Combination Product	10/14/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/14/2014

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)