MORNING FRESH- sodium fluoride paste

Morning Fresh by

Drug Labeling and Warnings

Morning Fresh by is a Otc medication manufactured, distributed, or labeled by Patcos Cosmetics (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Fluoride 0.22 %

Purpose: Anticavity

Use

• Aids in the prevention of dental cavities.

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:

• 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

Patcos Toothpaste

Patcos Toothpaste 1.jpg

INGREDIENTS AND APPEARANCE

MORNING FRESH 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68121-174
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68121-174-01	43 g in 1 TUBE; Type 0: Not a Combination Product	05/14/2014
2	NDC: 68121-174-02	78 g in 1 TUBE; Type 0: Not a Combination Product	05/14/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/14/2014

Labeler - Patcos Cosmetics (India) Private Limited (916169451)

Establishment
Name	Address	ID/FEI	Business Operations
Patcos Cosmetics (India) Private Limited		675973979	manufacture(68121-174)